REGISTER INFORMATION PAGE
Vol. 36 Iss. 17 - April 13, 2020

The Virginia Register OF REGULATIONS is an official state publication issued every other week throughout the year. Indexes are published quarterly, and are cumulative for the year. The Virginia Register has several functions. The new and amended sections of regulations, both as proposed and as finally adopted, are required by law to be published in the Virginia Register. In addition, the Virginia Register is a source of other information about state government, including petitions for rulemaking, emergency regulations, executive orders issued by the Governor, and notices of public hearings on regulations.

ADOPTION, AMENDMENT, AND REPEAL OF REGULATIONS

An agency wishing to adopt, amend, or repeal regulations must first publish in the Virginia Register a notice of intended regulatory action; a basis, purpose, substance and issues statement; an economic impact analysis prepared by the Department of Planning and Budget; the agency’s response to the economic impact analysis; a summary; a notice giving the public an opportunity to comment on the proposal; and the text of the proposed regulation.

Following publication of the proposal in the Virginia Register, the promulgating agency receives public comments for a minimum of 60 days. The Governor reviews the proposed regulation to determine if it is necessary to protect the public health, safety and welfare, and if it is clearly written and easily understandable. If the Governor chooses to comment on the proposed regulation, his comments must be transmitted to the agency and the Registrar no later than 15 days following the completion of the 60-day public comment period. The Governor’s comments, if any, will be published in the Virginia Register. Not less than 15 days following the completion of the 60-day public comment period, the agency may adopt the proposed regulation.

The Joint Commission on Administrative Rules (JCAR) or the appropriate standing committee of each house of the General Assembly may meet during the promulgation or final adoption process and file an objection with the Registrar and the promulgating agency. The objection will be published in the Virginia Register. Within 21 days after receipt by the agency of a legislative objection, the agency shall file a response with the Registrar, the objecting legislative body, and the Governor.

When final action is taken, the agency again publishes the text of the regulation as adopted, highlighting all changes made to the proposed regulation and explaining any substantial changes made since publication of the proposal. A 30-day final adoption period begins upon final publication in the Virginia Register.

The Governor may review the final regulation during this time and, if he objects, forward his objection to the Registrar and the agency. In addition to or in lieu of filing a formal objection, the Governor may suspend the effective date of a portion or all of a regulation until the end of the next regular General Assembly session by issuing a directive signed by a majority of the members of the appropriate legislative body and the Governor. The Governor’s objection or suspension of the regulation, or both, will be published in the Virginia Register. If the Governor finds that changes made to the proposed regulation have substantial impact, he may require the agency to provide an additional 30-day public comment period on the changes. Notice of the additional public comment period required by the Governor will be published in the Virginia Register.

The agency shall suspend the regulatory process for 30 days when it receives requests from 25 or more individuals to solicit additional public comment, unless the agency determines that the changes have minor or inconsequential impact.

A regulation becomes effective at the conclusion of the 30-day final adoption period, or at any other later date specified by the promulgating agency, unless (i) a legislative objection has been filed, in which event the regulation, unless withdrawn, becomes effective on the date specified, which shall be after the expiration of the 21-day objection period; (ii) the Governor exercises his authority to require the agency to provide for additional public comment, in which event the regulation, unless withdrawn, becomes effective on the date specified, which shall be after the expiration of the period for which the Governor has provided for additional public comment; (iii) the Governor and the General Assembly exercise their authority to suspend the effective date of a regulation until the end of the next regular legislative session; or (iv) the agency suspends the regulatory process, in which event the regulation, unless withdrawn, becomes effective on the date specified, which shall be after the expiration of the 30-day public comment period and no earlier than 15 days from publication of the readopted action.

A regulatory action may be withdrawn by the promulgating agency at any time before the regulation becomes final.

FAST-TRACK RULEMAKING PROCESS

Section 2.2-4012.1 of the Code of Virginia provides an exemption from certain provisions of the Administrative Process Act for agency regulations deemed by the Governor to be noncontroversial.  To use this process, Governor's concurrence is required and advance notice must be provided to certain legislative committees.  Fast-track regulations will become effective on the date noted in the regulatory action if no objections to using the process are filed in accordance with § 2.2-4012.1.

EMERGENCY REGULATIONS

Pursuant to § 2.2-4011 of the Code of Virginia, an agency, upon consultation with the Attorney General, and at the discretion of the Governor, may adopt emergency regulations that are necessitated by an emergency situation. An agency may also adopt an emergency regulation when Virginia statutory law or the appropriation act or federal law or federal regulation requires that a regulation be effective in 280 days or less from its enactment. The emergency regulation becomes operative upon its adoption and filing with the Registrar of Regulations, unless a later date is specified. Emergency regulations are limited to no more than 18 months in duration; however, may be extended for six months under certain circumstances as provided for in § 2.2-4011 D. Emergency regulations are published as soon as possible in the Register.

During the time the emergency status is in effect, the agency may proceed with the adoption of permanent regulations through the usual procedures. To begin promulgating the replacement regulation, the agency must (i) file the Notice of Intended Regulatory Action with the Registrar within 60 days of the effective date of the emergency regulation and (ii) file the proposed regulation with the Registrar within 180 days of the effective date of the emergency regulation. If the agency chooses not to adopt the regulations, the emergency status ends when the prescribed time limit expires.

STATEMENT

The foregoing constitutes a generalized statement of the procedures to be followed. For specific statutory language, it is suggested that Article 2 (§ 2.2-4006 et seq.) of Chapter 40 of Title 2.2 of the Code of Virginia be examined carefully.

CITATION TO THE VIRGINIA REGISTER

The Virginia Register is cited by volume, issue, page number, and date. 34:8 VA.R. 763-832 December 11, 2017, refers to Volume 34, Issue 8, pages 763 through 832 of the Virginia Register issued on
December 11, 2017.

The Virginia Register of Regulations is published pursuant to Article 6 (§ 2.2-4031 et seq.) of Chapter 40 of Title 2.2 of the Code of Virginia.

Members of the Virginia Code Commission: John S. Edwards, Chair; James A. "Jay" Leftwich, Vice Chair; Ryan T. McDougle; Nicole Cheuk; Rita Davis; Leslie L. Lilley; Thomas M. Moncure, Jr.; Christopher R. Nolen; Charles S. Sharp; Samuel T. Towell; Malfourd W. Trumbo.

Staff of the Virginia Register: Karen Perrine, Registrar of Regulations; Anne Bloomsburg, Assistant Registrar; Nikki Clemons, Regulations Analyst; Rhonda Dyer, Publications Assistant; Terri Edwards, Senior Operations Staff Assistant.


PUBLICATION SCHEDULE AND DEADLINES
Vol. 36 Iss. 17 - April 13, 2020

April 2020 through May 2021

Volume: Issue

Material Submitted By Noon*

Will Be Published On

36:18

April 8, 2020

April 27, 2020

36:19

April 22. 2020

May 11, 2020

36:20

May 4, 2020 (Monday)

May 25, 2020

36:21

May 20, 2020

June 8, 2020

36:22

June 3, 2020

June 22, 2020

36:23

June 17, 2020

July 6, 2020

36:24

July 1, 2020

July 20, 2020

36:25

July 15, 2020

August 3, 2020

36:26

July 29, 2020

August 17, 2020

37:1

August 12, 2020

August 31, 2020

37:2

August 26, 2020

September 14, 2020

37:3

September 9, 2020

September 28, 2020

37:4

September 23, 2020

October 12, 2020

37:5

October 7, 2020

October 26, 2020

37:6

October 21, 2020

November 9, 2020

37:7

November 4, 2020

November 23, 2020

37:8

November 16, 2020 (Monday)

December 7, 2020

37:9

December 2, 2020

December 21, 2020

37:10

December 14, 2020 (Monday)

January 4, 2021

37:11

December 28, 2020 (Monday)

January 18, 2021

37:12

January 13, 2021

February 1, 2021

37:13

January 27, 2021

February 15, 2021

37:14

February 10, 2021

March 1, 2021

37:15

February 24, 2021

March 15, 2021

37:16

March 10, 2021

March 29, 2021

37:17

March 24, 2021

April 12, 2021

37:18

April 7, 2021

April 26, 2021

37:19

April 21, 2021

May 10, 2021

*Filing deadlines are Wednesdays unless otherwise specified.


PERIODIC REVIEWS AND SMALL BUSINESS IMPACT REVIEWS
Vol. 36 Iss. 17 - April 13, 2020

TITLE 16. LABOR AND EMPLOYMENT

SAFETY AND HEALTH CODES BOARD

Agency Notice

Pursuant to Executive Order 14 (as amended July 16, 2018) and §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the following regulations are undergoing a periodic review and a small business impact review: 16VAC25-11, Public Participation Guidelines, and 16VAC25-180, Virginia Field Sanitation Standard, Agriculture. This review of the regulation will be guided by the principles in Executive Order 14 (as amended July 16, 2018).

The purpose of this review is to determine whether this regulation should be repealed, amended, or retained in its current form. Public comment is sought on the review of any issue relating to this regulation, including whether the regulation (i) is necessary for the protection of public health, safety, and welfare or for the economical performance of important governmental functions; (ii) minimizes the economic impact on small businesses in a manner consistent with the stated objectives of applicable law; and (iii) is clearly written and easily understandable.

Public comment begins April 13, 2020, and ends May 4, 2020.

Comments must include the commenter's name and address (physical or email) information in order to receive a response to the comment from the agency.

Following the close of the public comment period, a report of findings of both reviews will be posted on the Virginia Regulatory Town Hall and published in the Virginia Register of Regulations.

Contact Information: Holly Trice, Senior Staff Attorney, Regulatory Coordinator, Department of Labor and Industry, 600 East Main Street, Suite 207, Richmond, VA 23219, telephone (804) 786-2641, FAX (804) 371-6524, or email holly.trice@doli.virginia.gov.

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TITLE 22. SOCIAL SERVICES

DEPARTMENT FOR AGING AND REHABILITATIVE SERVICES

Report of Findings

Pursuant to §§ 2.2-4007.1 and 2.2-4017 of the Code of Virginia, the Department for Aging and Rehabilitative Services conducted a periodic review and a small business impact review of 22VAC30-40, Protections of Participants in Human Research, and determined that this regulation should be amended to achieve consistency with new federal requirements.

The final regulatory action to amend 22VAC30-40, which is published in this issue of the Virginia Register, serves as the report of findings.

Contact Information: Charlotte Arbogast, Policy Advisor, Department for Aging and Rehabilitative Services, 8004 Franklin Farms Drive, Richmond, VA 23229, telephone (804) 662-7093, FAX (804) 662-7663, TTY (800) 464-9950, or email charlotte.arbogast@dars.virginia.gov.

REGULATIONS
Vol. 36 Iss. 17 - April 13, 2020

TITLE 18. PROFESSIONAL AND OCCUPATIONALLICENSING
COMMON INTEREST COMMUNITY BOARD
Final Regulation

REGISTRAR'S NOTICE: The Common Interest Community Board is claiming an exemption from Article 2 of the Administrative Process Act in accordance with § 2.2-4006 A 4 a of the Code of Virginia, which excludes regulations that are necessary to conform to changes in Virginia statutory law or the appropriation act where no agency discretion is involved. The board will receive, consider, and respond to petitions by any interested person at any time with respect to reconsideration or revision.

Title of Regulation: 18VAC48-30. Condominium Regulations (amending 18VAC48-30-120, 18VAC48-30-670).

Statutory Authority: § 54.1-2349 of the Code of Virginia.

Effective Date: June 1, 2020.

Agency Contact: Trisha Henshaw, Executive Director, Common Interest Community Board, Department of Professional and Occupational Regulation, 9960 Mayland Drive, Suite 400, Richmond, VA 23233, telephone (804) 367-8510, FAX (866) 490-2723, or email cic@dpor.virginia.gov.

Summary:

The amendments (i) remove the requirement regarding registering a trade or fictitious name with the clerk of court in the locality where the business is conducted to conform the regulation to Chapter 594 of the 2017 Acts of Assembly, which became effective January 1, 2020, and (ii) make a technical amendment.

18VAC48-30-120. Prerequisites for registration.

The following provisions are prerequisites for registration and are supplementary to the provisions of § 55.1-1977 of the Code of Virginia.

A. 1. The declarant shall own or have the right to acquire an estate in the land constituting or to constitute the condominium that is of at least as great a degree and duration as the estate to be conveyed in the condominium units.

B. 2. The condominium instruments must be adequate to bring a condominium into existence upon recordation except that the certification requirements of § 55.1-1920 of the Code of Virginia need not be complied with as a prerequisite for registration. This subsection does not apply to condominium instruments that may be recorded after the condominium has been created.

C. 3. The declarant shall have filed with the board reasonable evidence of its financial ability to complete all proposed improvements on the condominium. Such evidence may include (i) financial statements and a signed affidavit attesting that the declarant has sufficient funds to complete all proposed improvements on the condominium and that the funds will be used for completion of the proposed improvements or (ii) proof of a commitment of an institutional lender to advance construction funds to the declarant and, to the extent that any such commitments will not furnish all the necessary funds, other evidence, satisfactory to the board, of the availability to the declarant of necessary funds. A lender's commitment may be subject to such conditions, including registration of the condominium units and presale requirements, as are normal for loans of the type and as to which nothing appears to indicate that the conditions will not be complied with or fulfilled.

1. a. In the case of a condominium located in Virginia, "proposed improvements" are improvements that are not yet begun or not yet complete and that the declarant is affirmatively and unconditionally obligated to complete under §§ 55.1-1920 and 55.1-1930 B of the Code of Virginia and applicable provisions of the condominium instruments or that the declarant would be so obligated to complete if plats and plans filed with the board in accordance with 18VAC48-30-140 A were recorded.

2. b. In the case of a condominium located outside of Virginia, "proposed improvements" are improvements that are not yet begun or not yet complete and that the declarant represents, without condition or limitation, will be built or placed in the condominium.

D. 4. The current and planned condominium marketing activities of the declarant shall comply with § 18.2-216 of the Code of Virginia, 18VAC48-30-80, and 18VAC48-30-660.

E. 5. The declarant shall have filed with the board (i) a proposed public offering statement that complies with this chapter and subsection A of § 55.1-1976 of the Code of Virginia and, if applicable, subsection B of § 55.1-1982 of the Code of Virginia; (ii) a substituted public offering statement that complies with this chapter; or (iii) a prospectus that complies with this chapter.

F. 6. Declarants may be organized as individuals or firms. Firms shall be organized as business entities under the laws of the Commonwealth of Virginia or otherwise authorized to transact business in Virginia. Firms shall register any trade or fictitious names with the State Corporation Commission or the clerk of court in the jurisdiction where the business is to be conducted in accordance with §§ 59.1-69 through 59.1-76 Chapter 5 of Title 59.1 (§ 59.1-69 et seq.) of the Code of Virginia before submitting an application to the board.

18VAC48-30-670. Condominium advertising standards.

A. No promise, assertion, representation, or statement of fact or opinion in connection with a condominium marketing activity shall be made that is false, inaccurate, or misleading by reason of inclusion of an untrue statement of a material fact or omission of a statement of a material fact relative to the actual or intended characteristics, circumstances, or features of the condominium or a condominium unit.

B. No promise, assertion, representation, or statement of fact or opinion made in connection with a condominium marketing activity shall indicate that an improvement will be built or placed on the condominium unless the improvement is a proposed improvement within the meaning of subsection C subdivision 3 of 18VAC48-30-120.

C. No promise, assertion, representation, or statement of fact or opinion made in connection with a condominium marketing activity and relating to a condominium unit not registered shall, by its express terms, induce, solicit, or encourage a prospective purchaser to leave Virginia for the purpose of executing a contract for sale or lease of the condominium unit or performing some other act that would create or purport to create a legal or equitable interest in the condominium unit other than a security interest in or a nonbinding reservation of the condominium unit.

NOTICE: Forms used in administering the regulation have been filed by the agency. The forms are not being published; however, online users of this issue of the Virginia Register of Regulations may click on the name of a form with a hyperlink to access it. The forms are also available from the agency contact or may be viewed at the Office of the Registrar of Regulations, 900 East Main Street, 11th Floor, Richmond, Virginia 23219.

FORMS (18VAC48-30)

Condominium Registration Application, A492-0517REG-v4 (rev. 1/2020)

Condominium Registration Application, A492-0517REG-v5 (rev. 4/2020)

Condominium Registration Application - Exhibit G - Bond to Insure Payment of Assessments, Sample Form, A492-0517BOND-v4 (rev. 1/2020)

Condominium Registration Application - Exhibit G - Irrevocable Letter of Credit, Sample Form, A492-0517LOC-v4 (rev. 1/2020)

Declarant Annual Report - Condominium, A492-0517ANRPT-v4 (rev. 1/2020)

Condominium Bond/Letter of Credit Verification Form, A492-0517BNDLOC-v2 (rev. 1/2020)

VA.R. Doc. No. R20-6307; Filed March 19, 2020, 1:38 p.m.
TITLE 18. PROFESSIONAL AND OCCUPATIONALLICENSING
COMMON INTEREST COMMUNITY BOARD
Final Regulation

REGISTRAR'S NOTICE: The Common Interest Community Board is claiming an exemption from Article 2 of the Administrative Process Act in accordance with § 2.2-4006 A 4 a of the Code of Virginia, which excludes regulations that are necessary to conform to changes in Virginia statutory law or the appropriation act where no agency discretion is involved. The board will receive, consider, and respond to petitions by any interested person at any time with respect to reconsideration or revision.

Title of Regulation: 18VAC48-45. Time-Share Regulations (amending 18VAC48-45-110, 18VAC48-45-360, 18VAC48-45-410, 18VAC48-45-620, 18VAC48-45-670).

Statutory Authority: §§ 54.1-2349 and 55.1-2247 of the Code of Virginia.

Effective Date: June 1, 2020.

Agency Contact: Trisha Henshaw, Executive Director, Common Interest Community Board, Department of Professional and Occupational Regulation, 9960 Mayland Drive, Suite 400, Richmond, VA 23233, telephone (804) 367-8510, FAX (866) 490-2723, or email cic@dpor.virginia.gov.

Summary:

The amendments remove the requirement regarding registering a trade or fictitious name with the clerk of court in the locality where the business is conducted to conform the regulation to Chapter 594 of the 2017 Acts of Assembly, which became effective January 1, 2020.

18VAC48-45-110. Prerequisites for registration of a time-share project.

The following provisions are prerequisites for registration and are supplementary to the provisions of § 55.1-2239 of the Code of Virginia.

1. The developer shall own or have the right to acquire an estate in the land constituting or to constitute the time-share project that is of at least as great a degree and duration as the estate to be conveyed in the time-shares.

2. The time-share instrument must be adequate to bring a time-share project into existence upon recordation. This subdivision does not apply to a time-share instrument that may be recorded after the time-share project has been created.

3. The time-share instrument must include a statement detailing that the developer reserves or does not reserve the right to add or delete any alternative purchase.

4. The current and planned time-share advertising activities of the developer shall comply with § 18.2-216 of the Code of Virginia and this chapter.

5. If the developer is a firm, it shall be organized as a business entity under the laws of the Commonwealth of Virginia or otherwise authorized to transact business in Virginia. Firms shall register any trade or fictitious names with the State Corporation Commission or the clerk of court in the jurisdiction where the business is to be conducted in accordance with §§ 59.1-69 through 59.1-76 Chapter 5 of Title 59.1 (§ 59.1-69 et seq.) of the Code of Virginia before submitting an application to the board.

18VAC48-45-360. Filing of amended public offering statement.

A. The developer shall promptly file with the board for review a copy of the amended public offering statement together with a copy of a summary of proposed amendments that shall be distributed to purchasers during the board review period. The summary of proposed amendments shall enumerate the amendments to the public offering statement submitted for board review and include a statement that the amendments to the public offering statement have been filed with the board but have not yet been accepted. The form of the submission is at the discretion of the developer provided that (i) all amendments are clearly represented in the documentation presented; (ii) the additions and deletions of text in the public offering statement and exhibits shall be identified by underlining and striking through text to be added and deleted; and (iii) documents being added to or deleted from the contents of the public offering statement shall be clearly and accurately reflected in the table of contents utilizing underlines and strike-throughs for additions and deletions. In addition to the copies showing edits to the text, a clean copy of all new and amended documents shall be provided.

B. The amended public offering statement submitted to the board for review shall include the effective date of the amendments.

C. Within 30 days of receipt of the amended public offering statement, the board shall review the amended public offering statement and supporting materials to determine whether the amendment complies with this chapter. If the board's review determines that the amended public offering statement complies with this chapter, it shall notify the developer in writing and confirm the new effective date of the public offering statement.

D. If the board's review determines that the amended public offering statement does not comply with this chapter, it the board shall immediately notify the developer in writing that the review has determined the amended public offering statement is not in compliance and shall specify the particulars of such noncompliance. The developer shall then have 20 days in which to correct the particulars of noncompliance identified by the board. The developer may, prior to the completion of the 20-day correction period, request an extension in writing of the 20-day correction period. Upon expiration of the 20-day correction period, if requested corrections have not been made or a request for extension properly received, the board may issue a temporary cease and desist order in accordance with subdivision D 2 of § 55.1-2247 of the Code of Virginia to require the cessation of sales until such time as affirmative action as directed by the board is taken. Use of the noncompliant public offering statement may result in further action by the board pursuant to §§ 55.1-2247, 55.1-2251, and 55.1-2252 of the Code of Virginia.

E. Notwithstanding an extension of the 30-day period for review agreed to in writing by the board and developer, if the board does not perform the required review of the public offering statement in accordance with subsection C of this section, the amendment shall be deemed to comply with 18VAC48-45-150 through 18VAC48-45-310, and the new effective date shall be the effective date of the amendment provided pursuant to subsection B of this section.

F. In each case in which an amended document is filed pursuant to this section and the manner of its amendment is not apparent on the face of the document, the developer shall provide an indication of the manner and extent of amendment.

18VAC48-45-410. Board review of annual report for a time-share project registration.

A. During review of the annual report, the board may make inquiries or request additional documentation to amplify or clarify the information provided.

B. If the board does not accept the annual report and the annual report filing is not completed within 60 days of a request by the board for additional information, the board may take further action pursuant to §§ 55.1-2247, 55.1-2251, and 55.1-2252 of the Code of Virginia for failing to file an annual report as required by § 55.1-2242 of the Code of Virginia.

C. If the board does not perform the required review of the annual report within 30 days of receipt by the board, the annual report shall be deemed to comply with § 55.1-2242 of the Code of Virginia.

18VAC48-45-620. Board review of annual report for exchange program registration.

A. During review of the annual report, the board may make inquiries or request additional documentation to amplify or clarify the information provided.

B. If the board does not accept the annual report and the annual report filing is not completed within 60 days of a request by the board for additional information, the board may take further action pursuant to §§ 55.1-2247, 55.1-2251, and 55.1-2252 of the Code of Virginia for failing to file an annual report as required by subsection E of § 55.1-2219 of the Code of Virginia.

C. If the board does not perform the required review of the annual report within 30 days of receipt by the board, the annual report shall be deemed to comply with subsection E of § 55.1-2219 of the Code of Virginia.

18VAC48-45-670. Requirements for registration as a time-share reseller.

A. Individuals or firms that provide any time-share resale services shall submit an application on a form prescribed by the board and shall meet the requirements of this section, including:

1. The information contained in § 55.1-2244 of the Code of Virginia.

2. The application fee specified in 18VAC48-45-70.

3. All contact information applicable to the time-share reseller and the lead dealer.

B. Any individual or firm offering resale services as defined in § 55.1-2200 of the Code of Virginia shall be registered with the board. All names under which the time-share reseller conducts business shall be disclosed on the application. The name under which the firm conducts business and holds itself out to the public (i.e., the trade or fictitious name) shall also be disclosed on the application. Firms shall be organized as business entities under the laws of the Commonwealth of Virginia or otherwise authorized to transact business in Virginia. Firms shall register any trade or fictitious names with the State Corporation Commission or the clerk of court in the jurisdiction where the business is to be conducted in accordance with §§ 59.1-69 through 59.1-76 Chapter 5 of Title 59.1 (§ 59.1-69 et seq.) of the Code of Virginia before submitting an application to the board.

C. The applicant for a time-share reseller registration shall disclose the firm's mailing address and the firm's physical address. A post office box is only acceptable as a mailing address when a physical address is also provided.

D. In accordance with § 54.1-204 of the Code of Virginia, each applicant for a time-share reseller registration shall disclose the following information about the firm, the lead dealer, and any of the principals of the firm, if applicable:

1. All felony convictions.

2. All misdemeanor convictions in any jurisdiction that occurred within three years before the date of application.

3. Any plea of nolo contendere or finding of guilt regardless of adjudication or deferred adjudication shall be considered a conviction for the purposes of this section. The record of conviction certified or authenticated in such form as to be admissible in evidence under the laws of the jurisdiction where convicted shall be admissible as prima facie evidence of such guilt.

E. The applicant for time-share reseller registration shall be in compliance with the standards of conduct set forth in Part X (18VAC48-45-720 et seq.) of this chapter at the time of application, while the application is under review by the board, and at all times when the registration is in effect.

F. The applicant for time-share reseller registration, the lead dealer, and all principals of the firm shall be in good standing in Virginia and in every jurisdiction and with every board or administrative body where licensed, certified, or registered, and the board, in its discretion, may deny registration to any applicant who has been subject to, or whose lead dealer or principals have been subject to, any form of adverse disciplinary action, including reprimand, revocation, suspension or denial, imposition of a monetary penalty, required to complete remedial education, or any other corrective action, in any jurisdiction or by any board or administrative body or surrendered a license, certificate, or registration in connection with any disciplinary action in any jurisdiction prior to obtaining registration in Virginia.

G. The applicant for time-share reseller registration shall provide all relevant information about the firm, the lead dealer, and of the principals of the firm for the seven years prior to application on outstanding judgments, past-due tax assessments, defaults on bonds, or pending or past bankruptcies and specifically shall provide all relevant financial information related to providing resale services as defined in § 55.1-2200 of the Code of Virginia.

H. The application for time-share reseller registration shall include the exhibits required pursuant to 18VAC48-45-680.

NOTICE: Forms used in administering the regulation have been filed by the agency. The forms are not being published; however, online users of this issue of the Virginia Register of Regulations may click on the name of a form with a hyperlink to access it. The forms are also available from the agency contact or may be viewed at the Office of the Registrar of Regulations, 900 East Main Street, 11th Floor, Richmond, Virginia 23219.

FORMS (18VAC48-45)

Time-Share Registration/Amendment Application A492-0515REG-v3 (eff. 1/2020)

Time-Share Registration/Amendment Application A492-0515REG-v4 (eff. 4/2020)

Time-Share Annual Report A492-0515ANRPT-v5 (eff. 1/2020)

Time-Share Building Status Form A492-0515BLDST-v1 (eff. 9/2013)

Time-Share Bond/Letter of Credit Verification Form A492-0515BOND-v3 (eff. 1/2020)

Time-Share Exchange Program Registration Application A492-0516REG-v2 (eff. 1/2020)

Time-Share Exchange Program Registration Application A492-0516REG-v3 (eff. 4/2020)

Time-Share Exchange Program Annual Report A492-0516ANRPT-v2 (eff. 1/2020)

Alternative Purchase Registration Application A492-0524REG-v2 (eff. 1/2020)

Alternative Purchase Registration Application A492-0524REG-v3 (eff. 4/2020)

Alternative Purchase Annual Report A492-0524ANRPT-v2 (eff. 1/2020)

Time-Share Reseller Registration Application A492-0525REG-v3 (eff. 1/2020)

Time-Share Reseller Registration Application A492-0525REG-v4 (eff. 4/2020)

Time-Share Reseller Lead Dealer Change Form A492-0525LDCHG-v2 (eff. 1/2020)

VA.R. Doc. No. R20-6308; Filed March 19, 2020, 1:39 p.m.
TITLE 18. PROFESSIONAL AND OCCUPATIONALLICENSING
COMMON INTEREST COMMUNITY BOARD
Final Regulation

REGISTRAR'S NOTICE: The Common Interest Community Board is claiming an exemption from Article 2 of the Administrative Process Act in accordance with § 2.2-4006 A 4 a of the Code of Virginia, which excludes regulations that are necessary to conform to changes in Virginia statutory law or the appropriation act where no agency discretion is involved. The board will receive, consider, and respond to petitions by any interested person at any time with respect to reconsideration or revision.

Title of Regulation: 18VAC48-50. Common Interest Community Manager Regulations (amending 18VAC48-50-10, 18VAC48-50-30).

Statutory Authority: § 54.1-2349 of the Code of Virginia.

Effective Date: June 1, 2020.

Agency Contact: Trisha Henshaw, Executive Director, Common Interest Community Board, Department of Professional and Occupational Regulation, 9960 Mayland Drive, Suite 400, Richmond, VA 23233, telephone (804) 367-8510, FAX (866) 490-2723, or email cic@dpor.virginia.gov.

Summary:

The amendments remove the requirement regarding registering a trade or fictitious name with the clerk of court in the locality where the business is conducted to conform the regulation to Chapter 594 of the 2017 Acts of Assembly, which became effective January 1, 2020.

Part I
General

18VAC48-50-10. Definitions.

Section 54.1-2345 of the Code of Virginia provides definitions of the following terms and phrases as used in this chapter:

"Association"

"Board"

"Common interest community"

"Common interest community manager"

"Declaration"

"Governing board"

"Lot"

"Management services"

The following words, terms, and phrases when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Active status" means the status of a certificated person in the employ of a common interest community manager.

"Address of record" means the mailing address designated by the regulant to receive notices and correspondence from the board. Notice mailed to the address of record by certified mail, return receipt requested, shall be deemed valid notice.

"Applicant" means a common interest community manager who has submitted an application for licensure or an individual who has submitted an application for certification.

"Application" means a completed, board-prescribed form submitted with the appropriate fee and other required documentation.

"Certified principal or supervisory employee" refers to any individual who has principal responsibility for management services provided to a common interest community or who has supervisory responsibility for employees who participate directly in the provision of management services to a common interest community, and who holds a certificate issued by the board.

"Contact hour" means 50 minutes of instruction.

"Department" means the Virginia Department of Professional and Occupational Regulation.

"Direct supervision" means exercising oversight and direction of, and control over, the work of another.

"Firm" means a sole proprietorship, association, partnership, corporation, limited liability company, limited liability partnership, or any other form of business organization recognized under the laws of the Commonwealth of Virginia and properly registered, as may be required, with the Virginia State Corporation Commission.

"Principal responsibility" means having the primary obligation for the direct provision of management services provided to a common interest community.

"Regulant" means a common interest community manager as defined in § 54.1-2345 of the Code of Virginia who holds a license issued by the board or an individual who holds a certificate issued by the board.

"Reinstatement" means the process and requirements through which an expired license or certificate can be made valid without the regulant having to apply as a new applicant.

"Renewal" means the process and requirements for periodically approving the continuance of a license or certificate.

"Responsible person" means the employee, officer, manager, owner, or principal of the firm who shall be designated by each firm to ensure compliance with Chapter 23.3 (§ 54.1-2345 et seq.) of Title 54.1 of the Code of Virginia, and all regulations of the board, and to receive communications and notices from the board that may affect the firm. In the case of a sole proprietorship, the sole proprietor shall have the responsibilities of the responsible person.

"Sole proprietor" means any individual, not a corporation or other registered business entity, who is trading under his own name, or under an assumed or fictitious name pursuant to the provisions of §§ 59.1-69 through 59.1-76 Chapter 5 of Title 59.1 (§ 59.1-69 et seq.) of the Code of Virginia.

"Supervisory responsibility" means providing formal supervision of the work of at least one other person. The individual who has supervisory responsibility directs the work of another employee or other employees, has control over the work performed, exercises examination and evaluation of the employee's performance, or has the authority to make decisions personally that affect the management services provided.

18VAC48-50-30. Qualifications for licensure as a common interest community manager.

A. Firms that provide common interest community management services shall submit an application on a form prescribed by the board and shall meet the requirements set forth in § 54.1-2346 of the Code of Virginia, as well as the additional qualifications of this section.

B. Any firm offering management services as defined in § 54.1-2345 of the Code of Virginia shall hold a license as a common interest community manager. All names under which the common interest community manager conducts business shall be disclosed on the application. The name under which the firm conducts business and holds itself out to the public (i.e., the trade or fictitious name) shall also be disclosed on the application. Firms shall be organized as business entities under the laws of the Commonwealth of Virginia or otherwise authorized to transact business in Virginia. Firms shall register any trade or fictitious names with the State Corporation Commission or the clerk of court in the county or jurisdiction where the business is to be conducted in accordance with §§ 59.1-69 through 59.1-76 Chapter 5 of Title 59.1 (§ 59.1-69 et seq.) of the Code of Virginia before submitting an application to the board.

C. The applicant for a common interest community manager license shall disclose the firm's mailing address, the firm's physical address, and the address of the office from which the firm provides management services to Virginia common interest communities. A post office box is only acceptable as a mailing address when a physical address is also provided.

D. In accordance with § 54.1-204 of the Code of Virginia, each applicant for a common interest community manager license shall disclose the following information about the firm, the responsible person, and any of the principals of the firm:

1. All felony convictions.

2. All misdemeanor convictions in any jurisdiction that occurred within three years of the date of application.

3. Any plea of nolo contendere or finding of guilt regardless of adjudication or deferred adjudication shall be considered a conviction for the purposes of this section. The record of conviction certified or authenticated in such form as to be admissible in evidence under the laws of the jurisdiction where convicted shall be admissible as prima facie evidence of such guilt.

E. The applicant for a common interest community manager license shall submit evidence of a blanket fidelity bond or employee dishonesty insurance policy in accordance with § 54.1-2346 D of the Code of Virginia. Proof of current bond or insurance policy with the firm as the named bondholder or insured must be submitted in order to obtain or renew the license. The bond or insurance policy must be in force no later than the effective date of the license and shall remain in effect through the date of expiration of the license.

F. The applicant for a common interest community manager license shall be in compliance with the standards of conduct and practice set forth in Part V (18VAC48-50-140 et. seq.) of this chapter at the time of application, while the application is under review by the board, and at all times when the license is in effect.

G. The applicant for a common interest community manager license, the responsible person, and any principals of the firm shall be in good standing in Virginia and in every jurisdiction and with every board or administrative body where licensed, certified, or registered and the board, in its discretion, may deny licensure to any applicant who has been subject to, or whose principals have been subject to, or any firm in which the principals of the applicant for a common interest community manager license hold a 10% or greater interest have been subject to, any form of adverse disciplinary action, including but not limited to, reprimand, revocation, suspension or denial, imposition of a monetary penalty, required to complete remedial education, or any other corrective action, in any jurisdiction or by any board or administrative body or surrendered a license, certificate, or registration in connection with any disciplinary action in any jurisdiction prior to obtaining licensure in Virginia.

H. The applicant for a common interest community manager license shall provide all relevant information about the firm, the responsible person, and any of the principals of the firm for the seven years prior to application on any outstanding judgments, past-due tax assessments, defaults on bonds, or pending or past bankruptcies, and specifically shall provide all relevant financial information related to providing management services as defined in § 54.1-2345 of the Code of Virginia. The applicant for a common interest community manager license shall further disclose whether or not one or more of the principals who individually or collectively own more than a 50% equity interest in the firm are or were equity owners holding, individually or collectively, a 10% or greater interest in any other entity licensed by any agency of the Commonwealth of Virginia that was the subject of any adverse disciplinary action, including revocation of a license, within the seven-year period immediately preceding the date of application.

I. An applicant for a common interest community manager license shall hold an active designation as an Accredited Association Management Company by the Community Associations Institute.

J. Prior to July 1, 2012, in lieu of the provisions of subsection I of this section, an application for a common interest community manager license may be approved provided the applicant certifies to the board that the applicant has:

1. At least one supervisory employee, officer, manager, owner, or principal of the firm who is involved in all aspects of the management services offered and provided by the firm and who has satisfied one of the following criteria:

a. Holds an active designation as a Professional Community Association Manager by Community Associations Institute;

b. Has successfully completed a comprehensive training program as described in 18VAC48-50-250 B, as approved by the board, and has at least three years of experience in providing management services, the quality of which demonstrates to the board that the individual is competent to have supervisory responsibility or principal responsibility for management services;

c. Has successfully completed an introductory training program as described in 18VAC48-50-250 A, as approved by the board, and has at least five years of experience in providing management services, the quality of which demonstrates to the board that the individual is competent to have supervisory responsibility or principal responsibility for management services; or

d. Has not completed a board-approved training program but who, in the judgment of the board, has obtained the equivalent of such training program by documented course work that meets the requirements of a board-approved comprehensive training program as described in Part VI (18VAC48-50-230 et seq.) of this chapter, and has at least 10 years of experience in providing management services, the quality of which demonstrates to the board that the individual is competent to have supervisory responsibility or principal responsibility for management services.

2. At least 50% of persons in the firm with principal responsibility for management services to a common interest community in the Commonwealth of Virginia have satisfied one of the following criteria:

a. Hold an active designation as a Professional Community Association Manager and certify having provided management services for a period of 12 months immediately preceding application;

b. Hold an active designation as a Certified Manager of Community Associations by the National Board of Certification for Community Association Managers and certify having two years of experience in providing management services. Of the required two years experience, a minimum of 12 months of experience must have been gained immediately preceding application;

c. Hold an active designation as an Association Management Specialist and certify having two years of experience in providing management services. Of the required two years experience, a minimum of 12 months of experience must have been gained immediately preceding application; or

d. Have completed a comprehensive or introductory training program, as set forth in 18VAC48-50-250 A or B, and passed a certifying examination approved by the board and certify having two years experience in providing management services. Of the required two years experience, a minimum of 12 months of experience must have been gained immediately preceding application.

K. Effective July 1, 2012, the applicant for a common interest community manager license shall attest that all employees of the firm who have principal responsibility for management services provided to a common interest community or who have supervisory responsibility for employees who participate directly in the provision of management services to a common interest community shall, within two years after employment with the common interest community manager, hold a certificate as a certified principal or supervisory employee issued by the board or shall be under the direct supervision of a certified principal or supervisory employee.

L. Effective July 1, 2012, in lieu of the provisions of subsection I of this section, an application for a common interest community manager license may be approved provided the applicant certifies to the board that the applicant has at least one supervisory employee, officer, manager, owner, or principal of the firm who is involved in all aspects of the management services offered and provided by the firm and who has satisfied one of the following criteria:

1. Holds an active designation as a Professional Community Association Manager by Community Associations Institute;

2. Has successfully completed a comprehensive training program as described in 18VAC48-50-250 B, as approved by the board, and has at least three years of experience in providing management services, the quality of which demonstrates to the board that the individual is competent to have supervisory responsibility or principal responsibility for management services;

3. Has successfully completed an introductory training program as described in 18VAC48-50-250 A, as approved by the board, and has at least five years of experience in providing management services, the quality of which demonstrates to the board that the individual is competent to have supervisory responsibility or principal responsibility for management services; or

4. Has not completed a board-approved training program but who, in the judgment of the board, has obtained the equivalent of such training program by documented course work that meets the requirements of a board-approved comprehensive training program as described in Part VI (18VAC48-50-230 et seq.) of this chapter, and has at least 10 years of experience in providing management services, the quality of which demonstrates to the board that the individual is competent to have supervisory responsibility or principal responsibility for management services.

M. The firm shall designate a responsible person.

NOTICE: Forms used in administering the regulation have been filed by the agency. The forms are not being published; however, online users of this issue of the Virginia Register of Regulations may click on the name of a form with a hyperlink to access it. The forms are also available from the agency contact or may be viewed at the Office of the Registrar of Regulations, 900 East Main Street, 11th Floor, Richmond, Virginia 23219.

FORMS (18VAC48-50)

Common Interest Community Manager Change of Personnel Form, A492-0501MGTCHG-v2 (rev. 10/2018)

Common Interest Community Manager License Renewal Application, A492-0501REN-v4 (rev. 11/2019)

Common Interest Community Manager Training Program Approval Application, A492-05TRAPRV-v3 (rev. 10/2018)

Experience Verification Form, A492-0501_10EXPv2 (rev. 10/2018)

Common Interest Community Manager License Application, A492-0501LIC-v4 (rev. 11/2019)

Common Interest Community Manager License Application, A492-0501LIC-v5 (rev. 4/2020)

Common Interest Community Manager Principal or Supervisory Employee Certificate Application, A492-0510CERT-v2 (rev. 10/2018)

Principal or Supervisory Employee Certificate Renewal Form, A492-0510REN-v2 (rev. 10/2018)

Common Interest Community Manager Application Supplement Comprehensive Training Program Equivalency Form, A492-0501TREQ-v2 (rev. 10/2018)

VA.R. Doc. No. R20-6306; Filed March 19, 2020, 1:36 p.m.
TITLE 18. PROFESSIONAL AND OCCUPATIONALLICENSING
DEPARTMENT OF PROFESSIONAL AND OCCUPATIONAL REGULATION
Final Regulation

REGISTRAR'S NOTICE: The Department of Professional and Occupational Regulation is claiming an exemption from Article 2 of the Administrative Process Act in accordance with § 2.2-4006 A 6 of the Code of Virginia, which excludes regulations of the regulatory boards served by the Department of Professional and Occupational Regulation pursuant to Title 54.1 of the Code of Virginia that are limited to reducing fees charged to regulants and applicants. The department will receive, consider, and respond to petitions by any interested person at any time with respect to reconsideration or revision.

Title of Regulation: 18VAC120-30. Regulations Governing Polygraph Examiners (amending 18VAC120-30-100).

Statutory Authority: § 54.1-1802.1 of the Code of Virginia.

Effective Date: July 1, 2020.

Agency Contact: Eric L. Olson, Executive Director, Department of Professional and Occupational Regulation, 9960 Mayland Drive, Suite 400, Richmond, VA 23233, telephone (804) 367-7226, FAX (866) 430-1033, or email polygraph@dpor.virginia.gov.

Summary:

The amendment reduces the license renewal fees for polygraph examiners received on or before June 30, 2022, in compliance with § 54.1-113 of the Code of Virginia.

18VAC120-30-100. Fees.

A. All application fees for licenses and registrations are nonrefundable and shall not be prorated. The date of receipt by the department is the date that will be used to determine whether or not the fee is on time.

B. Application and examination fees must be submitted with the application for licensure. All other fees are discussed in greater detail in later sections of this chapter.

C. In the event that a check, money draft, or similar instrument for payment of a fee required by statute or regulation is not honored by the bank or financial institution named, the applicant or regulant shall be required to remit fees sufficient to cover the original fee, plus an additional processing charge set by the department.

D. 1. The following fees listed in the table apply:

FEE TYPE

AMOUNT DUE

WHEN DUE

Application for Examiner's License

$45

With application

Application for Examiner's License by Reciprocity

$95

With application

Application for Intern Registration

$75

With application

Application for Examiner's License by Examination

$200

With application

Reexamination

$200

With approval letter

Renewal

$55

Up to one calendar month after the expiration date on license

Reinstatement

$75

One to six calendar months after the expiration date on license

2. For renewal fees received on or before June 30, 2020 2022, the fee shall be $20.

VA.R. Doc. No. R20-6099; Filed March 24, 2020, 8:51 a.m.
TITLE 22. SOCIAL SERVICES
DEPARTMENT FOR AGING AND REHABILITATIVE SERVICES
Final Regulation

REGISTRAR'S NOTICE: For changes necessary to conform the regulation to the Code of Federal Regulations, this action is exempt pursuant to § 2.2-4006 A 4 c of the Code of Virginia, which excludes regulations that are necessary to meet the requirements of federal law or regulations, provided such regulations do not differ materially from those required by federal law or regulation. The Department for Aging and Rehabilitative Services is also claiming an exemption from Article 2 of the Administrative Process Act in accordance with § 2.2-4006 A 3, which excludes regulations that consist only of changes in style or form or corrections of technical errors, for other changes. The department will receive, consider, and respond to petitions by any interested person at any time with respect to reconsideration or revision.

Title of Regulation: 22VAC30-40. Protections of Participants in Human Research (amending 22VAC30-40-10, 22VAC30-40-40 through 22VAC30-40-110, 22VAC30-40-130, 22VAC30-40-160).

Statutory Authority: §§ 51.5-131 and 51.5-132 of the Code of Virginia.

Effective Date: May 14, 2020.

Agency Contact: Charlotte Arbogast, Policy Advisor, Department for Aging and Rehabilitative Services, 8004 Franklin Farms Drive, Richmond, VA 23229, telephone (804) 662-7093, FAX (804) 662-7663, TTY (800) 464-9950, or email charlotte.arbogast@dars.virginia.gov.

Summary:

The amendments, which are necessary to comport with federal regulatory changes, (i) update the list of types of vulnerable human subjects; (ii) establish new requirements regarding the information that must be given to prospective research subjects as part of the informed consent process; (iii) allow the use of broad consent (i.e., seeking prospective consent to unspecified future research) from a subject for storage, maintenance, and secondary research use of identifiable private information, as an optional alternative that an investigator may choose instead of conducting the research on nonidentified information, having the department's human research review committee (HRRC) waive the requirement for informed consent, or obtaining consent for a specific study; (iv) clarify current exempt categories for research involving minors and establish new exempt categories of research based on a human subject's risk profile, under some of which exempt research would be required to undergo HRRC limited review to ensure that there are adequate privacy safeguards for identifiable private information; (v) create a requirement for institutions based in the United States that are engaged in cooperative research to use a single institutional review board for that portion of the research that takes place within the United States, with certain exceptions; (vi) remove the requirement to conduct continuing review of ongoing research for studies that undergo expedited review by the HRRC and for studies that have completed study interventions and are merely analyzing study data or involve only observational follow up in conjunction with standard clinical care; (vii) update the role of the commissioner with regard to terminating or suspending projects; and (viii) make other minor changes for clarity and accuracy.

22VAC30-40-10. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Affiliated with the covered entity" means employed by the covered entity or a member of a household containing an employee of the covered entity.

"Agent" means any an individual performing department-designated activities or exercising department-delegated authority or responsibility.

"Assent" means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, shall not be construed as assent.

"Commissioner" means the Commissioner of the Department for Aging and Rehabilitative Services or the commissioner's designee.

"Covered entity" means the Department for Aging and Rehabilitative Services, the Wilson Workforce and Rehabilitation Center, sheltered workshops, or independent living centers.

"Department" means the Department for Aging and Rehabilitative Services.

"Guardian" means an individual who is authorized under applicable state or local law to consent on behalf of a minor to general medical care.

"Human Research Review Committee" or "HRRC" means the committee established in accordance with and for the purposes expressed in this chapter.

"HRRC approval" means the determination of the HRRC that the research has been reviewed and may be conducted within the constraints set forth by the HRRC and by other department, state, and federal requirements.

"Human participant" or "human subject" means a living individual about whom an investigator (whether, whether professional or student) student, conducting research obtains:

1. Data through intervention or interaction with the individual; or

2. Identifiable private information.

"Human subject research" means a systematic investigation, experiment, study, evaluation, demonstration, or survey designed to develop or contribute to general knowledge (basic research) or specific knowledge (applied research) in which a living individual about whom an investigator (whether, whether professional or student) student, conducting research obtains data through intervention or interaction with the individual or obtains identifiable private information.

"Identifiable private information" means information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record or social security number). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) to constitute research involving human subjects private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

"Independent living center" means a consumer-controlled, community-based, cross disability, nonresidential private nonprofit agency that:

1. Is designed and operated within a local community by individuals with disabilities; and

2. Provides an array of independent living services.

"Informed consent" means a process by which the investigator fully explains the research activities and ensures that the prospective subject has sufficient opportunity to ask questions and has sufficient time to make a decision whether or not to participate in the research prior to signing the HRRC-approved written consent document. Informed consent must shall be prospectively obtained without coercion, include all of the basic elements of informed consent as specified in 22VAC30-40-100 B, be legally effective, contain no exculpatory language, and as required, include the additional elements of informed consent specified in 22VAC30-40-100 C and in accordance with 22VAC30-40-100.

"Institution" means any public or private entity or agency (including, including federal, state, and other agencies) agencies.

"Interaction" means communication or interpersonal contact between investigator and subject.

"Intervention" means both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or subject's environment that are performed for research purposes.

"Investigator" means the person, whether professional or student, who conducts the research.

"IRB" means an institutional review board.

"Legally authorized representative," as defined in § 32.1-162.16 of the Code of Virginia, means, in the following specified order of priority:

1. The parent or parents having custody of a prospective subject who is a minor;

2. The agent appointed under an advance directive, as defined in § 54.1-2982 of the Code of Virginia, executed by the prospective subject, provided the advance directive authorizes the agent to make decisions regarding the prospective subject's participation in human research;

3. The legal guardian of a prospective subject;

4. The spouse of the prospective subject, except where a suit for divorce has been filed and the divorce decree is not yet final;

5. An adult child of the prospective subject;

6. A parent of the prospective subject, when the subject is an adult;

7. An adult brother or sister sibling of the prospective subject; or

8. Any person or judicial or other body authorized by law or regulation to consent on behalf of a prospective subject to such the subject's participation in the particular human research.

For the purposes of this definition, any person authorized by law or regulation to consent on behalf of a prospective subject to such the subject's participation in the particular human research shall include an attorney-in-fact appointed under a durable power of attorney, to the extent the power grants the authority to make such a decision. The attorney-in-fact shall not be employed by the person, institution, or agency conducting the human research. No official or employee of the institution or agency conducting or authorizing the research shall be qualified to act as a legally authorized representative.

"Minimal risk" means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

"Minor," as defined in § 1-207 of the Code of Virginia, means an individual who is less younger than 18 years of age.

"Nontherapeutic research" means human subject research in which there is no reasonable expectation of direct benefit to the physical or mental condition of the subject.

"Parent" means a minor's biological or adoptive parent.

"Permission" means the agreement of parent(s) a parent or parents or a legally authorized representative to the participation of their minor or ward in research.

"Private information" means information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, or information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record). Private information must be individually identifiable (i.e., the identity of the human participant is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human participants.

"Research" means a systematic investigation designed to develop or contribute to generalizable knowledge (basic research) or specific knowledge (applied research). Activities that meet this definition constitute research for purposes of this chapter, whether or not they are supported or funded under a program that is considered research for other purposes. For example, some "demonstration" and "service" programs may include research activities.

"Sheltered workshop" means a program that (i) provides directly or facilitates the provision of one or more vocational rehabilitation services enumerated in 34 CFR 361.5(b)(9)(i) 361.5(c)(7)(i) to individuals with disabilities to enable them to maximize their opportunities for employment, including career advancement; (ii) has a vendor relationship with the department; and (iii) is not operated by a community services board.

"Written" or "in writing" means text or other human communication on a tangible medium (e.g., paper) or in an electronic format.

22VAC30-40-40. General provisions for conducting human subjects research.

A. No human subjects research may shall be conducted by a covered entity without the informed consent of the subject or the subject's legally authorized representative. The required elements of informed consent are provided in 22VAC30-40-100. The consent of the human subject or the human subject's legally authorized representative to participate in the research must shall be documented in writing and supported by the signature of a witness not involved in the conduct of the research, except as provided for in 22VAC30-40-100 J L. The investigator shall ensure that a knowledgeable member of the research team signs and provides human subjects of a research project with a copy of the written, informed consent document as defined in 22VAC30-40-100 B. The investigator shall make arrangements for those who need special assistance in understanding the consequences of participating in the research.

B. Each human subjects research project shall be approved by the department's HRRC as provided by this chapter.

C. Nontherapeutic research is shall be prohibited unless the HRRC determines that such nontherapeutic research will not present greater than minimal risk to human subjects.

D. The investigator shall be required to notify all human subjects of the risks caused by the research that are discovered after the research has concluded.

E. 22VAC30-40-160 applies shall apply to all research involving minors as subjects conducted or supported by the covered entity. In addition to other responsibilities assigned to the HRRC under 22VAC30-40-160, the HRRC shall review research covered by 22VAC30-40-160 and approve only research that satisfies the conditions of all applicable sections of this chapter. Exemptions in subdivisions 1 and 3 through 6 of 22VAC30-40-80 are applicable to 22VAC30-40-160. The exemption in subdivision 2 of 22VAC30-40-80 regarding educational tests is also applicable to 22VAC30-40-160. However, the exemption in subdivision 2 of 22VAC30-40-80 for research involving survey or interview procedures or observations of public behavior does not apply to research covered by 22VAC30-40-160, except for research involving observation of public behavior when the investigator or investigators do not participate in the activities being observed. Notwithstanding this subsection, some projects involving minors may qualify as exempt research as outlined in 22VAC30-40-80 and as approved by the HRRC. Such qualifications are described in the following table:

Exempt Category

Potential Qualification

Category 1

May qualify as exempt

Category 2 and the project involves observation of public behavior when the investigators do not participate in the activities being observed

May qualify as exempt

Category 2 and the project involves:

(i) Surveys or interviews;

(ii) The investigator's participation in the activities being observed; or

(iii) Educational testing, sensitive information, and identifiers collected with responses

Cannot qualify as exempt

Category 3

Cannot qualify as exempt

Category 4

May qualify as exempt

Category 5

May qualify as exempt

Category 6

May qualify as exempt

Category 7

May qualify as exempt

Category 8

May qualify as exempt

F. Cooperative research projects are shall be those projects covered by this chapter that involve a covered entity in conjunction with an institution(s) institution. In the conduct of cooperative research projects, the covered entity and each institution are shall be responsible for safeguarding the rights and welfare of human subjects and for complying with this chapter. With the approval of the commissioner, a covered entity participating in a cooperative project may enter into a joint review arrangement, rely upon the review of another qualified institutional review board (IRB) IRB, or make similar arrangements for avoiding duplication of effort.

G. In the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve human subjects in the research, the research shall first shall be reviewed and approved by the HRRC, as provided in this chapter, a certification submitted by the covered entity to the commissioner, and final approval given to of the proposed change shall be given by the commissioner.

H. With respect to any research project or any class of research projects, the commissioner may impose additional conditions prior to or at the time of approval when, in the judgment of the commissioner, additional conditions are necessary for the protection of human subjects.

I. In reviewing proposed research projects, the HRRC shall consider the requirements of review stated in 22VAC30-40-70.

22VAC30-40-50. Certification process.

A. No later than 45 days after the end of each state fiscal year, the Wilson Workforce and Rehabilitation Center, sheltered workshops, and independent living centers shall send a written report to the commissioner giving assurance that either all human subjects research conducted during the fiscal year was reviewed and approved by the department's HRRC prior to implementation of that research or that no human subjects research was conducted during that state fiscal year.

B. At the time that the research is approved by the HRRC, the HRRC chairperson shall send to the commissioner a description of the research project to be undertaken, which shall include a statement of the criteria for inclusion of prospective human subjects in the research project, a description of what will be done to prospective human subjects, and the type of review performed by the HRRC.

C. The commissioner may inspect the records of the department's HRRC.

D. The HRRC shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the HRRC's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the HRRC's action and shall be reported promptly to the research investigator, the commissioner, the head(s) heads of other appropriate covered entities, and in the case of cooperative research, the institutional officials responsible for human subjects research.

E. Research covered by this chapter that has been approved by the HRRC may be subject to further appropriate review and approval or disapproval by officials of the covered entities. However, those officials may shall not approve the research if it the research has not been approved by the HRRC.

22VAC30-40-60. Composition of the HRRC.

A. The HRRC shall have at least five members, appointed by the commissioner, with varying backgrounds to promote complete and adequate review of research projects commonly conducted by covered entities. The HRRC shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural background, and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research projects, the HRRC shall be able to ascertain the acceptability of proposed research in terms of the department's commitments and regulations, applicable law, standards of professional conduct and practice, and community attitudes. If the HRRC regularly reviews research that involves a vulnerable category of subjects, such as children, pregnant women, or persons with mental disabilities prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects. Additional membership requirements may be imposed on the HRRC by 34 CFR 350.4(c) and 356.3(c) for research sponsored by the National Institute on Disability and Rehabilitation Research. When minors with disabilities or persons with mental disabilities intellectual or developmental disabilities are purposefully included as research subjects, the HRRC's membership must shall include at least one person who is primarily concerned with the welfare of these research subjects.

B. Every nondiscriminatory effort will shall be made to ensure that the HRRC does not consist entirely of men or entirely of women, including the department's consideration of qualified persons of both sexes, so long as no selection is made to the HRRC on the basis of gender. The HRRC may shall not consist entirely of members of one profession.

C. The HRRC shall include:

1. At least one member whose primary concerns are in nonscientific areas;

2. At least one member who is not otherwise affiliated with any a covered entity and who is not part of the immediate family of a person who is affiliated with the a covered entity; and

3. At least one member whose primary concerns are in the scientific areas.

D. The HRRC shall not have a member participate in the HRRC's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the HRRC. The HRRC has responsibility for determining whether a member has a conflicting interest. The HRRC member shall be replaced in the case of conflicting interest resulting in a decrease of the HRRC below to fewer than five members.

E. The HRRC may, at its discretion, may invite individuals with competence in special areas to assist in the review of complex issues which that require expertise beyond or in addition to that available on the HRRC. These individuals may not vote.

F. A quorum of the HRRC shall consist of a majority of its members, including at least one member whose primary concerns are in nonscientific areas. Except when exempt or expedited review procedures are used, proposed research shall be reviewed at convened meetings at which a majority of members is present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.

G. The HRRC and the department shall establish procedures and rules of operation necessary to fulfill the requirements of these regulations this chapter.

22VAC30-40-70. Elements of the HRRC's review process.

A. The HRRC shall review and have authority to approve, require modifications in, or disapprove all research activities covered by this chapter.

B. The HRRC shall require that information given to prospective subjects as part of the informed consent process is in accordance with 22VAC30-40-100. The HRRC may require that information, in addition to that specifically mentioned in 22VAC30-40-100, be given to prospective subjects when, in the HRRC's judgment, the information would meaningfully add to the protection of the rights and welfare of subjects.

C. The HRRC shall require documentation of informed consent or may waive documentation in accordance with 22VAC30-40-100 J L.

D. The HRRC shall consider research proposals within 45 days after submission of a complete application to the HRRC's chairperson. In order for the research to be approved, it shall receive the approval of a majority of those members present at a meeting in which a quorum exists. The HRRC shall notify investigators and the covered entity in writing of its decision to approve or disapprove the research, or of modifications required to secure HRRC approval.

E. The HRRC shall develop written complaint procedures to be followed by a human subject who has a concern(s) concern about a research project in which he is participating or has participated.

F. Any participant who has a complaint about a research project in which he is participating or has participated shall be referred to the chairperson of the HRRC, who shall refer it the complaint to the HRRC to determine if there has been a violation of the research protocol as approved by the HRRC.

G. The committee HRRC shall require periodic reports. The, the frequency of such reports which should reflect the nature and degree of risk of each research project.

H. If the HRRC decides to disapprove a research application, it the HRRC shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

I. The HRRC shall conduct continuing review of research covered by this chapter at intervals appropriate to the degree of risk, but not less often than once per year, and shall have authority to observe or have a third party observe the consent process and the research. Unless the HRRC determines otherwise, continuing review of research shall not be required in the following circumstances:

1. Research eligible for expedited review in accordance with 22VAC30-40-90;

2. Research reviewed by the HRRC in accordance with the limited IRB review described in 22VAC30-40-80 B 3, 22VAC30-40-80 C 1 c, and 22VAC30-40-80 G and H; or

3. Research that has progressed to the point that it involves only one or both of the following, which are part of the HRRC-approved study:

a. Data analysis, including analysis of identifiable private information; or

b. Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.

J. In order to approve research covered by this chapter, the HRRC shall determine that all of the following requirements are satisfied:

1. Risks to subjects are minimized:

a. By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk; and

b. Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the HRRC should consider only those risks and benefits that may result from the research (as as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research) research. The HRRC should not consider possible long-range effects of applying knowledge gained in the research (for example (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

3. Selection of subjects is equitable. In making this assessment, the HRRC should take into account the purposes of the research and the setting in which the research will be conducted and. The HRRC should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, pregnant women, persons with mental disabilities, or economically or educationally disadvantaged persons prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.

4. Informed consent will be is sought from each prospective subject or the subject's legally authorized representative in accordance with and to the extent required by 22VAC30-40-100.

5. Informed consent will be is appropriately documented in accordance with and to the extent required by 22VAC30-40-100.

6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

K. For purposes of conducting the limited review required by 22VAC30-40-80-G, the HRRC need not make the determinations at subdivisions J 1 through J 7 of this section and shall make the following determinations:

1. Broad consent for storage, maintenance, and secondary research use of identifiable private information is obtained in accordance with the requirements of 22VAC30-40-100 A and D;

2. Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance with 22VAC30-40-100 L; and

3. If there is a change made for research purposes in the way the identifiable private information is stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

8. L. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, pregnant women, persons with mental disabilities prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, there are additional safeguards have been included in the project place to protect the rights and welfare of these the human subjects.

22VAC30-40-80. Kinds of research exempt from committee review.

Research activities in which the only involvement of human participants will shall be in limited to one or more of the following categories are shall be exempt from these regulations this chapter unless the research is covered by other sections of this chapter. The HRRC shall determine whether the proposed research project satisfies at least one of the following exemption category categories in this section before the research can may be conducted pursuant to the exemption provided under this section:

1. Category 1. Research conducted in established or commonly accepted educational settings, involving normal educational practices that are not likely to impact adversely student opportunity to learn required educational content or the assessment of educators who provide instruction, such as:

a. Research on regular and special education instructional strategies; or

b. Research on the effectiveness of or the comparison among instructional techniques, curriculum, or classroom management methods.

2. Category 2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, or achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording), unless:

a. Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and

b. Any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or

c. The information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects and the HRRC conducts a limited review to make the determination required by 22VAC30-40-70 J 7.

3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under subdivision 2 of 22VAC30-40-80 if:

a. The human subjects are elected or appointed public officials or candidates for public office; or

b. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

3. Category 3. Research involving benign behavioral interventions.

a. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses, including data entry, or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

(1) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;

(2) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or

(3) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and the HRRC conducts a limited review to make the determination required by 22VAC30-40-70 J 7.

b. For the purpose of this subsection, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, and not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all of these criteria are met, examples of benign behavioral interventions include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

c. If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless a subject authorizes the deception through a prospective agreement to participate in research in circumstances in which a subject is informed that he will be unaware of or misled regarding the nature or purposes of the research.

4. Category 4. Secondary research for which consent is not required: Secondary research using identifiable private information, if at least one of the following criteria is met:

Research involving a. The research involves the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the;

b. The information is recorded by the investigator in such a manner that subjects (i) cannot be identified, directly or through identifiers linked to the subjects; (ii) the investigator does not contact the subjects; and (iii) the investigator will not reidentify the subject;

c. The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR Part 160, General Administrative Requirements, and Part 164, Security and Privacy, Subparts A and E, for the purposes of "health care operations'' or "research'' as those terms are defined at 45 CFR 164.501 or for "public health activities and purposes'' as described under 45 CFR 164.512(b); or

d. The research is conducted by, or on behalf of, the department using department-generated or department-collected information obtained for nonresearch activities if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with § 208(b) of the E-Government Act of 2002, 44 USC § 3501 note; if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 USC § 552a; and if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 USC § 3501 et seq.

5. Category 5. Research and demonstration projects that are conducted by or subject to the approval of the commissioner, and that which are designed to study, evaluate, or otherwise examine:

a. Public benefit or service programs;

b. Procedures for obtaining benefits or services under those programs;

c. Possible changes in or alternatives to those programs or procedures; or

d. Possible changes in methods or levels of payment for benefits or services under those programs.

6. Category 6. Taste and food quality evaluation and consumer acceptance studies:

a. If wholesome foods without additives are consumed; or

b. If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

7. Category 7. Storage or maintenance for secondary research for which broad consent is required. Storage or maintenance of identifiable private information for potential secondary research use if the HRRC conducts a limited review and makes the determinations required by 22VAC30-40-70 J 8.

8. Category 8. Secondary research for which broad consent is required: Research involving the use of identifiable private information, if it meets the following criteria:

a. Broad consent for the storage, maintenance, and secondary research use of the identifiable private information is obtained in accordance with 22VAC30-40-100 A and D;

b. Documentation of informed consent or waiver of documentation of consent is obtained in accordance with 22VAC30-40-100 L;

c. The HRRC conducts a limited review and makes the determination required by 22VAC30-40-70 J 7 and makes the determination that the research to be conducted is within the scope of the broad consent referenced in subdivision 1 of this subsection; and

d. The investigator does not include returning individual research results to subjects as part of the study plan. The investigator shall not be prevented from abiding by any legal requirements to return individual research results.

22VAC30-40-90. Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.

A. The HRRC may use the expedited review procedure for categories of research that are listed in 63 FR 60364-60367 where either or both one or more of the following apply:

1. Some or all of the research appearing on the list and found by the reviewer(s) reviewer to involve no more than minimal risk.

2. Minor changes in previously approved research during the period (of of one year or less) less for which approval is authorized; or

3. Research for which limited review is a condition of exemption under 22VAC30-40-80 B 3, 22VAC30-40-80 C 1 c, and 22VAC30-40-80 G and H.

Under an expedited review procedure, the review may be carried out by the HRRC chairperson or by one or more experienced reviewers designated by the chairperson from among members of the HRRC. In reviewing the research, reviewers may exercise all of the authorities of the HRRC except that reviewers may not disapprove the research. A research proposal may be disapproved only after review by a convened meeting of the HRRC in which a quorum is present and in accordance with procedure set forth in 22VAC30-40-70.

B. When an expedited review procedure is used, the HRRC shall adopt a method for keeping all members advised of research proposals which have been approved under the expedited review procedure.

C. The commissioner may restrict, suspend, terminate, or choose not to authorize the HRRC's use of the expedited review procedure.

22VAC30-40-100. Informed consent.

A. Except as provided elsewhere in this chapter, no investigator may involve a human being as a subject in research covered by this chapter unless the investigator has obtained the legally effective informed consent of the prospective human subject or the prospective human subject's legally authorized representative in accordance with this chapter. The investigator shall seek such consent only under circumstances that provide the prospective human participant subject or the prospective human participant's subject's legally authorized representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the prospective human participant subject or the prospective human participant's subject's legally authorized representative shall be in language understandable to the prospective human participant subject or the prospective human participant's subject's legally authorized representative. The prospective human subject or the prospective human subject's legally authorized representative shall be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information. No informed consent, whether oral or written, may include any exculpatory language through which the human subject or the human subject's legally authorized representative is made to waive or appear to waive any of the human subject's legal rights, or releases or appears to release the investigator, the sponsor, the covered entity, or its agents from liability for negligence.

B. In seeking informed consent, the following basic elements shall be provided to each prospective human subject or prospective human subject's legally authorized representative:

1. A statement that the project involves research, an explanation of the purposes of the research and the expected duration of the human subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental;

2. A description of any reasonably foreseeable risks or discomforts to the human subject;

3. A description of any benefits to the human subject or to others that may reasonably be expected from the research;

4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might may be advantageous to the human subject;

5. A statement describing the extent, if any, to which confidentiality of records identifying the human subject will be maintained;

6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

7. An explanation of who to contact for answers to pertinent questions about the research and research the human subject's rights, and who to contact in the event of a research-related injury to the subject; and

8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the human subject is otherwise entitled, and the human subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and

9. One of the following statements about research that involves the collection of identifiable private information:

a. A statement that identifiers may be removed from the identifiable private information and that, after such removal, the information could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the human subject or the human subject's legally authorized representative, if this may be a possibility; or

b. A statement that the human subject's information collected as part of the research, even if identifiers are removed, shall not be used or distributed for future research studies.

C. When the HRRC determines that it is appropriate, one or more of the following additional elements of informed consent shall also shall be provided to each subject:

1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable;

2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;

3. Any additional costs to the subject that may result from participation in the research;

4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;

5. A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject; and

6. The approximate number of subjects involved in the project; and

7. A statement regarding whether clinically relevant research results, including individual research results, shall be disclosed to subjects, and if so, under what conditions.

D. Broad consent for the storage, maintenance, and secondary research use of identifiable private information (collected for either research studies other than the proposed research or nonresearch purposes) is permitted as an alternative to the informed consent requirements in subsections B and C of this section. If the subject or the subject's legally authorized representative is asked to provide broad consent, the following shall be provided to each subject or the subject's legally authorized representative:

1. The information required in subdivisions B 2, B 3, B 5, and B 8 of this section;

2. A general description of the types of research that may be conducted with the identifiable private information. This description shall include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted;

3. A description of the identifiable private information that may be used in research, whether sharing of identifiable private information may occur, and the types of institutions or researchers that may conduct research with the identifiable private information;

4. A description of the period of time that the identifiable private information may be stored and maintained, which period of time could be indefinite, and a description of the period of time that the identifiable private information may be used for research purposes, which period of time could be indefinite;

5. Unless the subject or legally authorized representative will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that may be conducted using the subject's identifiable private information, including the purposes of the research, and that they may have chosen not to consent to some of those specific research studies;

6. Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject; and

7. An explanation of whom to contact for answers to questions about the subject's rights and about storage and use of the subject's identifiable private information, and whom to contact in the event of a research-related harm.

D. E. The HRRC may approve a consent procedure that does not include or which that alters some or all of the elements of informed consent set forth in subsection B of this section, or waive waives the requirement to obtain informed consent provided the HRRC finds and documents that:

1. The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:

a. Public benefit or service programs;

b. Procedures for obtaining benefits or services under those programs;

c. Possible changes in or alternatives to those programs or procedures; or

d. Possible changes in methods or levels of payment for benefits or services under those programs; and

2. The research could not practicably be carried out without the waiver or alteration.

E. F. The HRRC may approve a consent procedure that does not include or that alters some or all of the elements of informed consent set forth in subsection B of this section, or waive the requirements to obtain informed consent provided the HRRC finds and documents that:

1. The research involves no more than minimal risk to the subject;

2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;

3. The research could not practicably be carried out without the waiver or alteration; and

4. If the research involves using identifiable private information, the research could not practicably be carried out without using such information in an identifiable format; and

5. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

F. G. The HRRC may approve a research proposal in which an investigator will obtain information for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject's legally authorized representative if either of the following conditions are met:

1. The investigator will obtain information through oral or written communication with the prospective subject or the prospective subject's legally authorized representative; or

2. The investigator will obtain identifiable private information by accessing records.

H. The informed consent requirements in this chapter are shall not intended to preempt any applicable federal, state, or local laws that require additional information to be disclosed in order for informed consent to be legally effective.

G. I. Nothing in this chapter is intended to shall limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal or state law, or local ordinance.

H. J. Notwithstanding consent by a legally authorized representative, no person shall be forced to participate in any human subject research. Each human subject shall be given a copy of the signed consent form required by this section, except Except as provided for in subsection J L of this section, human subjects shall be given a copy of the signed consent form required by this section.

I. K. No legally authorized representative may consent to nontherapeutic research unless the HRRC determines that such nontherapeutic research will present no more than a minor increase over minimal risk to the prospective subject. No nontherapeutic research shall be performed without the consent of the human subject.

J. L. Documentation of informed consent.

1. Except as provided in subdivision 3 of this subsection, informed consent shall be documented by the use of a written consent form approved by the HRRC and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.

2. Except as provided in subdivision 3 of this subsection, the consent form may be either of the following:

a. A written consent document that embodies the elements of informed consent required in subsection B of this section. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator shall give either the subject or the subject's legally authorized representative adequate opportunity to read it before it is signed; or

b. A short form written consent document stating that the elements of informed consent required in subsection B of this section have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the HRRC shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the legally authorized representative, in addition to a copy of the short form.

3. The HRRC may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

a. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or

b. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or

c. If the subjects or subjects' legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

4. In cases in which the documentation requirement is waived, the HRRC may require the investigator to provide subjects with a written statement regarding the research.

22VAC30-40-110. HRRC records.

A. The HRRC shall prepare and maintain adequate documentation of HRRC activities, including the following:

1. Copies of all research applications reviewed, scientific evaluations, if any, that accompany the applications, approved consent documents, progress reports submitted by investigators, and reports of injuries to subjects;

2. Minutes of HRRC meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the HRRC; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution;

3. Records of continuing review activities;

4. Copies of all correspondence between the HRRC and the investigators;

5. A list of all HRRC members identified by name; earned degrees; representative capacity; indications of experience such as board certifications, licenses, etc., sufficient to describe each member's chief anticipated contributions to HRRC deliberations; and any employment or other relationship between each member and the covered entity, for example: full-time employee, part-time employee, member of governing panel or board, or paid or unpaid consultant;

6. Statements of significant new findings provided to participants; and

7. Written procedures for the HRRC that shall include:

a. Conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the department;

b. Determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous HRRC review;

c. Ensuring prompt reporting to the HRRC of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which HRRC approval has already been given, may not be initiated without HRRC review and approval except when necessary to eliminate apparent immediate hazards to the subject; and

d. Ensuring prompt reporting to the HRRC and the commissioner of (i) any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the HRRC and (ii) any suspension or termination of HRRC approval.

8. The rationale for an expedited reviewer's determination under 22VAC30-40-90 A 1 that research appearing on the expedited review list described in 63 FR 30364-60367 is more than minimal risk.

9. As applicable, documentation specifying the responsibilities that the covered entity and another qualified IRB other than the HRRC, each shall undertake to ensure compliance with the requirements of this chapter when (i) nonexempt research involving human subjects or (ii) exempt research with a limited review is overseen by another qualified IRB other than the HRRC. Such documentation may include:

a. A written agreement between the covered entity and the qualified IRB that is not the HRRC;

b. Implementation of an institution-wide policy directive providing the allocation of responsibilities between the covered entity and the qualified IRB that is not the HRRC; or

c. A research protocol.

B. The records required by this chapter shall be retained for at least three years, and records relating to research which is conducted shall be retained for at least three years after completion of the research. All records may be maintained in printed or electronic form and shall be accessible for inspection and copying by authorized employees or agents of the department or federal agency at reasonable times and in a reasonable manner.

C. The HRRC shall ensure that an overview of approved human subject research projects and the results of such projects are made public on the department's website unless otherwise exempt from disclosure under the Virginia Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia).

D. The HRRC shall have access to meeting space and sufficient staff to support the HRRC's review and recordkeeping duties.

22VAC30-40-130. Role of the commissioner.

A. The commissioner shall maintain records of federal assurances, annual reports, and summary descriptions of research projects.

B. The commissioner shall review communications from the HRRC reporting violations of research protocols which that led to suspension or termination of the research to ensure that appropriate steps have been taken for the protection of the rights of human subjects.

C. The commissioner shall arrange for printing and dissemination of copies of these regulations this chapter.

D. The commissioner may require that support for a project be terminated or suspended in the manner prescribed in applicable program requirements when the commissioner finds a covered entity has materially failed to comply with the terms of this chapter.

E. In making decisions about supporting or approving applications or proposals covered by this chapter, the commissioner may take into account, in addition to all other eligibility requirements and program criteria, factors such as whether the applicant has been subject to a termination or suspension under subsection D of this section and whether the applicant or the person who would direct or has directed the scientific and technical aspects of an activity has, in the judgment of the commissioner, materially failed to discharge responsibility for the protection of the rights and welfare of human subjects (whether or not the research was subject to federal regulation).

22VAC30-40-160. Additional protection for minors involved as subjects in research.

A. Research not involving greater than minimal risk. The covered entity may conduct or fund research in which the HRRC finds that no greater than minimal risk to minors is presented, only if the HRRC finds that adequate provisions are made for soliciting the assent of the minors and the permission of their parents or guardians, pursuant to subsection E of this section.

B. Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. The covered entity may conduct or fund research in which the HRRC finds that more than minimal risk to minors is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject's well-being, only if the HRRC finds that:

1. The risk is justified by the anticipated benefit to the subjects;

2. The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and

3. Adequate provisions are made for soliciting the assent of the minors and permission of their parents or guardians, pursuant to subsection E of this section.

C. Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition. The covered entity may conduct or fund research in which the HRRC finds that more than minimal risk to minors is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is not likely to contribute to the well-being of the subject, only if the HRRC finds that:

1. The risk represents a minor increase over minimal risk;

2. The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;

3. The intervention or procedure is likely to yield generalizable knowledge about the subjects' subject's disorder or condition that is of vital importance for the understanding or amelioration of the subjects' subject's disorder or condition; and

4. Adequate provisions are made for soliciting assent of the minors and permission of their parents or guardians, pursuant to subsection E of this section.

D. Research not otherwise approvable that presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of minors. The covered entity may conduct or fund research that the HRRC does not believe meets the requirements pursuant to subsection A, B, or C of this section only if:

1. The HRRC finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of minors; and

2. The Secretary of the United States Department of Education, after consultation with a panel of experts in pertinent disciplines (for example: (e.g., science, medicine, education, ethics, or law) and following opportunity for public review and comment, has determined either that:

a. The research in fact satisfies the conditions pursuant to subsection A, B, or C of this section, as applicable; or

b. (i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of minors; (ii) the research will be conducted in accordance with sound ethical principles; and (iii) adequate provisions are made for soliciting the assent of minors and the permission of their parents or guardians, pursuant to subsection E of this section.

E. Requirements for permission by parents or guardians and for assent by minors.

1. In addition to the determinations required under other applicable subsections of this section, the HRRC shall determine that adequate provisions are made for soliciting the assent of the minors, if in the judgment of the HRRC the minors are capable of providing assent. In determining whether minors are capable of assenting, the HRRC shall take into account the ages, maturity, and psychological state of the minors involved. This judgment may be made for all minors to be involved in research under a particular protocol, or for each minor, as the HRRC deems appropriate. If the HRRC determines that the capability of some or all of the minors is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the minors and is available only in the context of the research, the assent of the minors is not a necessary condition for proceeding with the research. Even if the HRRC determines that the subjects are capable of assenting, the HRRC may still may waive the assent requirement under circumstances in which consent may be waived in accord with 22VAC30-40-100.

2. In addition to the determinations required under other applicable subsections of this section, the HRRC shall determine, in accordance with and to the extent that consent is required by 22VAC30-40-100, that adequate provisions are made for soliciting the permission of each minor's parent(s) parent or parents or guardian(s) guardian. If parental permission is to be obtained, the HRRC may find that the permission of one parent is sufficient for research to be conducted pursuant to subsection A or B of this section. If research is covered pursuant to subsections C and D of this section and permission is to be obtained from parents, both parents must shall give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or if only one parent has legal responsibility for the care and custody of the minor. Only the legal custodial parent can is able to give informed consent.

3. In addition to the provisions for waiver contained in 22VAC30-40-100, if the HRRC determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused minors), it may waive the consent requirements in 22VAC30-40-100 and subdivision 2 of this subsection, provided an appropriate mechanism for protecting the minors who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with federal, state, or local law. The choice of an appropriate mechanism depends upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.

4. Permission by parents or guardians must shall be documented in accordance with and to the extent required by 22VAC30-40-100 J L.

5. If the HRRC determines that assent is required, it shall also determine whether and how assent must shall be documented.

F. Wards.

1. Minors who are wards of the state or any other agency, institution, or entity may be included in research approved under subsection C or D of this section only if that research is:

a. Related to their status as wards; or

b. Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of minors involved as subjects are not wards.

2. If research is approved under subdivision 1 of this subsection, the HRRC shall require appointment of an advocate for each minor who is a ward, in addition to any other individual acting on behalf of the minor as guardian or in loco parentis. One individual may serve as advocate for more than one minor. The advocate must shall be an individual who has the background and experience to act in, and agrees to act in, the best interest of the minor for the duration of the minor's participation in the research and who is not associated in any way (except, except in the role as advocate or member of the HRRC) HRRC, with the research, the investigator or investigators, or the guardian organization.

VA.R. Doc. No. R20-5670; Filed March 24, 2020, 7:54 a.m.

Guidance Documents
Vol. 36 Iss. 17 - April 13, 2020

PUBLIC COMMENT OPPORTUNITY

Pursuant to § 2.2-4002.1 of the Code of Virginia, a certified guidance document is subject to a 30-day public comment period after publication in the Virginia Register of Regulations and prior to the guidance document's effective date. During the public comment period, comments may be made through the Virginia Regulatory Town Hall website (http://www.townhall.virginia.gov) or sent to the agency contact. Under subsection C of § 2.2-4002.1, the effective date of the guidance document may be delayed for an additional period. The guidance document may also be withdrawn.

The following guidance documents have been submitted for publication by the listed agencies for a public comment period. Online users of this issue of the Virginia Register of Regulations may click on the name of a guidance document to access it. Guidance documents are also available on the Virginia Regulatory Town Hall (http://www.townhall.virginia.gov) or from the agency contact or may be viewed at the Office of the Registrar of Regulations, 900 East Main Street, Richmond, Virginia 23219.

BOARD OF ACCOUNTANCY

Title of Document: Enforcement Processes.

Public Comment Deadline: May 13, 2020.

Effective Date: May 14, 2020.

Agency Contact: Nancy Glynn, Executive Director, Board of Accountancy, 9960 Mayland Drive, Suite 402, Richmond, VA 23233, telephone (804) 367-8540, or email nancy.glynn@boa.virginia.gov.

DEPARTMENT OF MEDICAL ASSISTANCE SERVICES

Title of Document: Availability of Physician Training for Medicaid Long Term Services and Supports Training.

Public Comment Deadline: May 13, 2020.

Effective Date: May 14, 2020.

Agency Contact: Emily McClellan, Regulatory Manager, Division of Policy and Research, Department of Medical Assistance Services, 600 East Broad Street, Suite 1300, Richmond, VA 23219, telephone (804) 371-6043, or email emily.mcclellan@dmas.virginia.gov.

BOARD OF SOCIAL WORK

Title of Document: Content for Training on Supervision for Clinical Social Work.

Public Comment Deadline: May 13, 2020.

Effective Date: May 14, 2020.

Agency Contact: Elaine J. Yeatts, Agency Regulatory Coordinator, Department of Health Professions, Perimeter Center, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4688, or email elaine.yeatts@dhp.virginia.gov.

GOVERNOR
Vol. 36 Iss. 17 - April 13, 2020

EXECUTIVE ORDER NUMBER FIFTY-ONE (2020)

Declaration of a State of Emergency Due to Novel Coronavirus (COVID-19)

Importance of the Issue

The Commonwealth of Virginia is monitoring an outbreak of a respiratory illness referred to as the coronavirus (COVID-19), which has spread from Wuhan, Hubei Province, China to more than 80 other locations internationally, including the Commonwealth. The Virginia Department of Health (VDH) has been working with local, state, and federal officials, healthcare and emergency management experts, and various state agencies to form a COVID-19 Taskforce to prepare for and respond to this threat. Given recent confirmed occurrences of COVID-19 within the Commonwealth and in neighboring states, as well as information from the Centers for Disease Control and Prevention, it is anticipated that the disease will spread.

Therefore, on this date, March 12, 2020, I declare that a state of emergency exists in the Commonwealth of Virginia to continue to prepare and coordinate our response to the potential spread of COVID-19, a communicable disease of public health threat. The anticipated effects of COVID-19 constitute a disaster as described in § 44-146.16 of the Code of Virginia (Code). By virtue of the authority vested in me by Article V, Section 7 of the Constitution of Virginia, by §§ 44-146.17 and 44-75.1 of the Code of Virginia, as Governor and Director of Emergency Management and Commander-in-Chief of the Commonwealth’s armed forces, I proclaim a state of emergency. Accordingly, I direct state and local governments to render appropriate assistance to prepare for this event, to alleviate any conditions resulting from the situation, and to implement recovery and mitigation operations and activities so as to return impacted areas to pre-event conditions as much as possible. Emergency services shall be conducted in accordance with § 44-146.13 et seq. of the Code.

In order to marshal all public resources and appropriate preparedness, response, and recovery measures, I order the following actions:

A. Implementation by state agencies of the Commonwealth of Virginia Emergency Operations Plan, as amended, along with other appropriate state plans.

B. Activation of the Virginia Emergency Operations Center and the Virginia Emergency Support Team, as directed by the State Coordinator of Emergency Management, to coordinate the provision of assistance to state, local, and tribal governments and to facilitate emergency services assignments to other agencies.

C. Authorization for the heads of executive branch agencies, on behalf of their regulatory boards as appropriate, and with the concurrence of their Cabinet Secretary, to waive any state requirement or regulation, and enter into contracts without regard to normal procedures or formalities, and without regard to application or permit fees or royalties. All waivers issued by agencies shall be posted on their websites.

D. Activation of § 59.1-525 et seq. of the Code related to price gouging.

E. Activation of the Virginia National Guard to State Active Duty.

F. Authorization of a maximum of $10,000,000 in state sum sufficient funds for state and local government mission assignments and state response and recovery operations authorized and coordinated through the Virginia Department of Emergency Management allowable by The Stafford Act, 42 USC § 5121 et seq. Included in this authorization is $1,000,000 for the Department of Military Affairs, if it is called to State Active Duty.

Effective Date of this Executive Order

This Executive Order shall be effective March 12, 2020, and shall remain in full force and in effect until June 10, 2020, unless sooner amended or rescinded by further executive order.

Termination of this Executive Order is not intended to terminate any federal type benefits granted or to be granted due to injury or death as a result of service under this Executive Order.

Given under my hand and under the Seal of the Commonwealth of Virginia, this 12th day of March, 2020.

/s/ Ralph S. Northam
Governor

EXECUTIVE ORDER NUMBER FIFTY-TWO (2020)

Increases in Hospital Bed Capacity in Response to Novel Coronavirus (COVID-19)

Importance of the Issue

The Commonwealth of Virginia anticipates a sudden, yet temporary need to increase bed capacity in general hospitals and nursing homes within the Commonwealth. The increase may be needed to serve persons who become acutely ill due to the outbreak of a respiratory illness referred to as the novel coronavirus (COVID-19). Based on information from the Virginia Department of Health and the Centers for Disease Control and Prevention, the number of cases of COVID-19 continues to increase within the Commonwealth and in neighboring states. It is anticipated that the number of persons who will need to be admitted to a hospital or nursing home for care within our communities may exceed the current capacity of our hospitals and nursing homes. Certain requirements in the Code of Virginia limit the ability of our hospitals and nursing homes to increase quickly their bed capacity in response to this expected higher demand.

Directive

Therefore, by virtue of the authority vested in me by the Constitution of Virginia, by §§ 2.2-103 and 44-146.13 et seq. of the Code of Virginia, and notwithstanding the provisions of Article 1.1 of Chapter 4 of Title 32.1 of the Code, I direct the State Health Commissioner, at his discretion, to authorize any general hospital or nursing home to increase licensed bed capacity as determined necessary by the Commissioner to respond to increased demand for beds resulting from COVID-19. Notwithstanding § 32.1-132 of the Code of Virginia, I further direct any beds added by a general hospital or nursing home pursuant to an authorization of the Commissioner under this Order will constitute licensed beds that do not require further approval or the issuance of a new license.

These actions are in concert with, and further the provisions of, Executive Order 51 in marshalling all resources and appropriate preparedness, response, and recovery measures to respond to the emergency. Any authorization by the Commissioner to increase bed capacity, and the authority for any resulting increased number of beds, will expire 30 days after the expiration or rescission of Executive Order 51, as it may be amended.

Effective Date of this Executive Order

This Executive Order shall be effective March 20, 2020, and shall remain in full force and in effect until July 10, 2020, unless sooner amended or rescinded by further executive order.

Given under my hand and under the Seal of the Commonwealth of Virginia, this 20th day of March, 2020.

/s/ Ralph S. Northam
Governor

EXECUTIVE ORDER NUMBER FIFTY-THREE (2020)

Temporary Restrictions on Restaurants, Recreational, Entertainment, Gatherings,
Non-Essential Retail Businesses, and Closure of
K-12 Schools due to Novel Coronavirus (COVID-19)

Importance of the Issue

The Commonwealth of Virginia continues to respond to the novel coronavirus (COVID-19) pandemic. On March 13, 2020, I ordered all K-12 schools in the Commonwealth closed for two weeks. On March 17, 2020, I, along with the Virginia State Health Commissioner, issued an Order of the Governor and State Health Commissioner Declaration of Public Health Emergency (later amended) limiting the number of patrons in restaurants, fitness centers, and theaters to no more than 10 per establishment. Despite these measures, COVID-19 presents an ongoing threat to our communities. Information from the Virginia Department of Health reveals occurrences of the virus in every region of the Commonwealth. Indeed, the data suggests that in several regions there may be community spread of the virus.

Now, we must take additional long term action to mitigate the impacts of this virus on our Commonwealth. Guidance on School Closures from the Centers for Disease Control and Prevention indicates that medium term closures (8-20 weeks) have greater impact on minimizing the spread of COVID-19 than shorter term closures (2-8 weeks). This guidance is consistent with the expertise of public health officials and their models of continuing spread of COVID-19 throughout the Commonwealth and the nation. Unnecessary person-to-person contact increases the risk of transmission and community spread. Consequently, we must limit such interactions to those necessary to access food and essential materials. Protecting the health and ensuring the safety of every Virginian is my highest priority.

Directive

Therefore, by virtue of the authority vested in me by Article V, Section 7 of the Constitution of Virginia, by § 44-146.17 of the Code of Virginia and in furtherance of Executive Order 51, I order the following:

1. Effective 11:59 p.m., Tuesday, March 24, 2020 until 11:59 p.m., Thursday, April 23, 2020, all public and private in person gatherings of 10 or more individuals are prohibited.

2. Cessation of all in-person instruction at K-12 schools, public and private, for the remainder of the 2019-2020 school year. Facilities providing child care services may remain open. On March 18, 2020, the Commissioner of the Virginia Department of Social Services, Duke Storen, issued a letter with guidance for daycare providers operating in the Commonwealth, including group size limits of 10 and stringent public health guidelines to prevent the spread of COVID-19. That guidance remains effective and I urge all Virginians with school-age children to review it. In addition, I urge child care providers to prioritize services for children of essential personnel, while asking all families with the ability to keep their children home, to do so. To that end, the Virginia Department of Social Services and the Virginia Department of Education will issue guidance to communities about operationalizing emergency child care services for essential personnel.

3. Closure of all dining and congregation areas in restaurants, dining establishments, food courts, breweries, microbreweries, distilleries, wineries, tasting rooms, and farmers markets effective 11:59 p.m., Tuesday, March 24, 2020 until 11:59 p.m., Thursday, April 23, 2020. Restaurants, dining establishments, food courts, breweries, microbreweries, distilleries, wineries, tasting rooms, and farmers markets may continue to offer delivery and take-out services.

4. Closure of all public access to recreational and entertainment businesses, effective 11:59 p.m., Tuesday, March 24, 2020 until 11:59 p.m., Thursday, April 23, 2020 as set forth below:

 Theaters, performing arts centers, concert venues, museums, and other indoor entertainment centers;

Fitness centers, gymnasiums, recreation centers, indoor sports facilities, and indoor exercise facilities;

 Beauty salons, barbershops, spas, massage parlors, tanning salons, tattoo shops, and any other location where personal care or personal grooming services are performed that would not allow compliance with social distancing guidelines to remain six feet apart;

▪ Racetracks and historic horse racing facilities; and

▪ Bowling alleys, skating rinks, arcades, amusement parks, trampoline parks, fairs, arts and craft facilities, aquariums, zoos, escape rooms, indoor shooting ranges, public and private social clubs, and all other places of indoor public amusement.

5. Essential retail businesses may remain open during their normal business hours. Such businesses are:

▪ Grocery stores, pharmacies, and other retailers that sell food and beverage products or pharmacy products, including dollar stores, and department stores with grocery or pharmacy operations;

▪ Medical, laboratory, and vision supply retailers;

Electronic retailers that sell or service cell phones, computers, tablets, and other communications technology;

▪ Automotive parts, accessories, and tire retailers as well as automotive repair facilities;

Home improvement, hardware, building material, and building supply retailers;

▪ Lawn and garden equipment retailers;

▪ Beer, wine, and liquor stores;

▪ Retail functions of gas stations and convenience stores;

▪ Retail located within healthcare facilities;

 Banks and other financial institutions with retail functions;

▪ Pet and feed stores;

▪ Printing and office supply stores; and

▪ Laundromats and dry cleaners.

6. Effective 11:59 p.m., Tuesday, March 24, 2020 until 11:59 p.m., Thursday, April 23, 2020, any brick and mortar retail business not listed in paragraph 5 may continue to operate but must limit all in-person shopping to no more than 10 patrons per establishment. If any such business cannot adhere to the 10 patron limit with proper social distancing requirements, it must close.

7. All businesses shall, to the extent possible, adhere to social distancing recommendations, enhanced sanitizing practices on common surfaces, and other appropriate workplace guidance from state and federal authorities while in operation.

8. Although business operations offering professional rather than retail services may remain open, they should utilize teleworking as much as possible. Where telework is not feasible, such business must adhere to social distancing recommendations, enhanced sanitizing practices on common surfaces, and apply the relevant workplace guidance from state and federal authorities.

9. Nothing in the Order shall limit: (a) the provision of health care or medical services; (b) access to essential services for low-income residents, such as food banks; (c) the operations of the media; (d) law enforcement agencies; or (e) the operation of government.

Violation of paragraphs 1, 3, 4, and 6 of this Order shall be a Class 1 misdemeanor pursuant to § 44-146.17 of the Code of Virginia.

Effective Date of this Executive Order

This Executive Order shall be effective March 23, 2020, amends Amended Order of the Governor and State Health Commissioner Declaration of Public Health Emergency, Order of Public Health Emergency One, and shall remain in full force and in effect until amended or rescinded by further executive order.

Given under my hand and under the Seal of the Commonwealth of Virginia, this 23rd day of March, 2020.

/s/ Ralph S. Northam
Governor

EXECUTIVE ORDER NUMBER FIFTY-FOUR (2020)

Delegation of Authority to the Commissioner of the Virginia Employment Commission to Request
Title XII Advances to Support Virginia Workers

Importance of the Issue

Due to the novel coronavirus (COVID-19) public health emergency, many Virginians are out of work due to temporarily business closures, school closures, and other health-related emergencies. The United States Department of Labor is working on expanding the definition of who is eligible for unemployment benefits, an extension of time a person may be on unemployment benefits, and the amount of unemployment pay a dislocated worker receives per week. The increase in workers who are eligible as well as the increase in funds distributed to families in the Commonwealth will deplete the Virginia Unemployment Insurance Trust. The United States Department of Labor Employment and Training Administration issued guidance regarding on how to request and repay Title XII advances from the Federal Unemployment Account. Pursuant to that guidance, the Virginia Employment Commission must take action with the United States Department of Labor to secure benefits for Virginians.

Directive

Therefore, by virtue of the authority vested in me as Governor under Article V of the Constitution of Virginia, § 2.2-104 of the Code of Virginia, and my continuing and ultimate authority and responsibility to act in such matters, I hereby affirm and delegate to the Commissioner of the Virginia Employment Commission the authority and responsibility for executing agreements with the United States Department of Labor related to implement the SB 3548 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) and requesting Title XII advances from the Federal Unemployment Account.

Effective Date of this Executive Order

This Executive Order shall be effective upon its signing and shall remain in full force and effect until amended or rescinded by further executive order.

Given under my hand and under the Seal of the Commonwealth of Virginia this 28th day of March, 2020.

/s/ Ralph S. Northam
Governor

EXECUTIVE ORDER NUMBER FIFTY-FIVE (2020)

Temporary Stay at Home Order due to Novel Coronavirus (COVID-19)

To reinforce the Commonwealth's response to COVID-19 and in furtherance of Executive Orders 51 (March 12, 2020) and 53 (March 23, 2020) and by virtue of the authority vested in me by Article V, Section 7 of the Constitution of Virginia, by § 44-146.17 of the Code of Virginia, I order the following:

1. All individuals in Virginia shall remain at their place of residence, except as provided below by this Order and Executive Order 53. To the extent individuals use shared or outdoor spaces, whether on land or on water, they must at all times maintain social distancing of at least six feet from any other person, with the exception of family or household members or caretakers. Individuals may leave their residences for the purpose of:

a. Obtaining food, beverages, goods, or services as permitted in Executive Order 53;

b. Seeking medical attention, essential social services, governmental services, assistance from law enforcement, or emergency services;

c. Taking care of other individuals, animals, or visiting the home of a family member;

d. Traveling required by court order or to facilitate child custody, visitation, or child care;

e. Engaging in outdoor activity, including exercise, provided individuals comply with social distancing requirements;

f. Traveling to and from one's residence, place of worship, or work;

g. Traveling to and from an educational institution;

h. Volunteering with organizations that provide charitable or social services; and

i. Leaving one's residence due to a reasonable fear for health or safety, at the direction of law enforcement, or at the direction of another government agency.

2. All public and private in-person gatherings of more than ten individuals are prohibited. This includes parties, celebrations, religious, or other social events, whether they occur indoor or outdoor. This restriction does not apply:

a. To the operation of businesses not required to close to the public under Executive Order 53; or

b. To the gathering of family members living in the same residence.

3. Institutions of higher education shall cease all in-person classes and instruction, and cancel all gatherings of more than ten individuals. For purposes of facilitating remote learning, performing critical research, or performing essential functions, institutions of higher education may continue to operate, provided that social distancing requirements are maintained.

4. Effective April 1, 2020, at 11:59 p.m., cessation of all reservations for overnight stays of less than 14 nights at all privately-owned campgrounds, as defined in § 35.1-1 of the Code of Virginia.

5. Closure of all public beaches as defined in § 10.1-705 of the Code of Virginia for all activity, except exercising and fishing. Social distancing requirements must be followed.

6. All relevant state agencies shall continue to work with all housing partners to execute strategies to protect the health, safety, and well-being of Virginians experiencing homelessness during this pandemic and to assist Virginians in avoiding evictions or foreclosures.

7. As provided in Executive Order 53, nothing in this Order shall limit: (a) the provision of health care or medical services; (b) access to essential services for low-income residents, such as food banks; (c) the operations of the media; (d) law enforcement agencies; or (e) the operation of government.

Violation of paragraphs 2, 3, 4, and 5 of this Order shall be a Class 1 misdemeanor pursuant to § 44-146.17 of the Code of Virginia.

Effective Date of this Executive Order

This Executive Order shall be effective March 30, 2020, amends Amended Order of the Governor and State Health Commissioner Declaration of Public Health Emergency, Order of Public Health Emergency One and Executive Order 53, and shall remain in full force and in effect until June 10, 2020, unless amended or rescinded by further executive order.

Given under my hand and under the Seal of the Commonwealth of Virginia, this 30th day of March, 2020.

/s/ Ralph S. Northam
Governor

Amended Order of the Governor and State Health Commissioner Declaration of Public Health Emergency

Order of Public Health Emergency One

WHEREAS, the State Health Commissioner declared COVID-19 a disease of public health threat on February 7, 2020; and

WHEREAS, Virginia Governor Ralph S. Northam declared a state of emergency due to COVID-19 on March 12, 2020 in Executive Order No. 51 by virtue of the authority vested in the Governor by Article V, Section 7 of the Constitution of Virginia and by §§ 44-146.17 and 44-75.1 of the Code of Virginia; and

WHEREAS, COVID-19 spreads from person-to-person, transmitted via respiratory droplets, and can be spread from an infected person who does not have symptoms to another person; and

WHEREAS, no current vaccine or known treatment options exist at this time; and

WHEREAS, the Commonwealth of Virginia, seeks to contain, control, and prevent additional COVID-19 infections and unnecessary risk to citizens; and

WHEREAS, on March 17, 2020, Virginia Governor Ralph S. Northam announced new measures to combat COVID-19 and support impacted Virginians; and

WHEREAS, in an effort to increase social distancing to inhibit spread of the virus, Virginia Governor Ralph S. Northam included in that announcement that all restaurants, fitness centers, and theaters are mandated to significantly reduce capacity to 10 patrons, or close; while encouraged to continue carry-out and takeaway options; and

WHEREAS, the State Health Commissioner desires to protect the public health of all Virginians by increasing social distancing in restaurants, fitness centers, and theaters; and

WHEREAS, pursuant to § 32.1-13 of the Code of Virginia, the State Health Commissioner, acting for the State Board of Health (Board) when it is not in session pursuant to § 32.1-20 of the Code of Virginia, is vested with authority to make separate orders to meet any emergency not provided for by general regulations, for the purpose of suppressing conditions dangerous to the public health and communicable, contagious, and infectious diseases; and

WHEREAS, pursuant to § 35.1-10 of the Code of Virginia, the State Health Commissioner may take whatever action he deems necessary, to include ordering immediate closure of a restaurant, to control the spread of a preventable disease.

NOW THEREFORE, the Governor and State Health Commissioner hereby issue this Order declaring a public health emergency resulting from the spread of COVID-19 virus affecting the health and safety of Virginians, and restrict the number of patrons allowed in restaurants, as defined in § 35.1-1 of the Code of Virginia, fitness centers, and theaters, as defined in § 15.2-2820 of the Code of Virginia, to 10 patrons or less in any such establishment in order to inhibit spread of the virus. Any willful violation or refusal, failure, or neglect to comply with this Order, issued pursuant to § 32.1-13 of the Code of Virginia, is punishable as a Class 1 misdemeanor pursuant to § 32.1-27 of the Code of Virginia.

In addition, the observation of 11 or more patrons in a restaurant may result in immediate operation permit suspension per the Food Regulations at 12VAC5-421-3770 (Summary Suspension of a Permit) by a district health director as authorized by the State Health Commissioner.

The State Health Commissioner may also seek injunctive relief in circuit court for violation of this Order pursuant to § 32.1-27 of the Code of Virginia.

WHEREAS, this Order hereby amends the Order dated March 17, 2020, shall be effective as of March 16, 2020, and shall remain in full force and effect until amended or rescinded. Citation of this Order shall be Commonwealth of Virginia Amended Order of Public Health Emergency One.

Given under my hand and under the Seal of the Office of the State Health Commissioner of the Commonwealth of Virginia this 20th Day of March 2020.

/s/ Ralph S. Northam
Governor

/s/ M. Norman Oliver, MD, MA
State Health Commissioner

Order of the Governor and State Health Commissioner

Order of Public Health Emergency Two

WHEREAS, the State Health Commissioner declared COVID-19 a disease of public health threat on February 7, 2020; and

WHEREAS, Virginia Governor Ralph S. Northam declared a state of emergency due to COVID-19 on March 12, 2020 in Executive Order No. 51 by virtue of the authority vested in the Governor by Article V, Section 7 of the Constitution of Virginia and by §§ 44-146.17 and 44-75.1 of the Code of Virginia; and

WHEREAS, the Governor and State Health Commissioner issued Order of Public Health Emergency One on March 17, 2020, as amended on March 20, 2020, declaring a public health emergency; and

WHEREAS, COVID-19 spreads from person-to-person, transmitted via respiratory droplets, and can be spread from an infected person who does not have symptoms to another person; and

WHEREAS, no current vaccine or known treatment options exist at this time; and

WHEREAS, the supply chain in the Commonwealth for health care personal protective equipment (PPE), to include gowns, masks, face shields and respirators, has been severely disrupted by the significant increased use of such equipment worldwide in response to COVID-19, such that there are now critical shortages of this equipment for health care workers; and

WHEREAS, it is anticipated that due to the continuing spread of COVID-19, a critical shortage of needed hospital beds will result; and

WHEREAS, the Commonwealth of Virginia seeks to curtail the spread of the COVID-19 pandemic in the Commonwealth, protect our health care workers, and ensure sufficient hospital beds necessary to serve Virginians' medical needs; and

WHEREAS, pursuant to § 32.1-13 of the Code of Virginia, the State Health Commissioner, acting for the State Board of Health when it is not in session pursuant to § 32.1-20 of the Code of Virginia, is vested with authority to make separate orders to meet any emergency not provided for by general regulations, for the purpose of suppressing conditions dangerous to the public health and communicable, contagious, and infectious diseases.

NOW THEREFORE, the Governor and State Health Commissioner hereby issue this Order prohibiting all inpatient and outpatient surgical hospitals licensed under 12VAC5-410, free-standing endoscopy centers, physicians' offices, and dental, orthodontic, and endodontic offices in the Commonwealth from providing procedures and surgeries that require PPE, which if delayed, are not anticipated to cause harm to the patient by negatively affecting the patient's health outcomes, or leading to disability or death. This does not include outpatient visits delivered in hospital-based clinics.

This Order does not apply to the full suite of family planning services and procedures nor to treatment for patients with emergency or urgent needs. Inpatient and outpatient surgical hospitals licensed under 12VAC5-410, free-standing endoscopy centers, physicians' offices, and dental, orthodontic, and endodontic offices may perform any procedure or surgery that if delayed or canceled would result in the patient's condition worsening. Outpatient surgical hospitals are encouraged to work with their local inpatient hospitals to assist with surge capacity needs.

Any willful violation or refusal, failure, or neglect to comply with this Order, issued pursuant to § 32.1-13 of the Code of Virginia, is punishable as a Class 1 misdemeanor pursuant to § 32.1-27 of the Code of Virginia. The State Health Commissioner may also seek injunctive relief in circuit court for violation of this Order pursuant to § 32.1-27 of the Code of Virginia.

WHEREAS, this Order shall remain in full force and effect until April 24, 2020. Citation of this Order shall be Commonwealth of Virginia Order of Public Health Emergency Two.

Given under my hand and under the Seal of the Office of the State Health Commissioner of the Commonwealth of Virginia this 25th Day of March, 2020.

/s/ Ralph S. Northam
Governor

/s/ M. Norman Oliver, MD, MA
State Health Commissioner

GENERAL NOTICES/ERRATA
Vol. 36 Iss. 17 - April 13, 2020

DEPARTMENT OF BEHAVIORAL HEALTH AND DEVELOPMENTAL SERVICES

COVID-19 Page on Department Website for Community Providers

In recent days and weeks, the Department of Behavioral Health and Developmental Services (DBHDS) has received many questions from community services boards and private providers in the community about how to handle COVID-19. A list of frequently asked questions (FAQs) and provider communications have been developed and an email address designated where community providers can submit questions directly to DBHDS staff. The FAQs will be continuously updated as more questions and responses are reviewed and developed. Other resources are listed at www.dbhds.virginia.gov/covid19.

Contact Information: Ruth Anne Walker, Director of Regulatory Affairs, Department of Behavioral Health and Developmental Services, Jefferson Building, 1220 Bank Street, 4th Floor, Richmond, VA 23219, telephone (804) 225-2252, FAX (804) 371-4609, TDD (804) 371-8977, or email ruthanne.walker@dbhds.virginia.gov.

DEPARTMENT OF ENVIRONMENTAL QUALITY

Sweet Sue Solar LLC Notice of Intent for Small Renewable Energy Project (Solar) - King William County

Sweet Sue Solar LLC has provided the Department of Environmental Quality notice of intention to submit the necessary documentation for a permit by rule for a small renewable energy project (solar) in King William County. Sweet Sue Solar Energy Center will consist of a 77-megawatt solar generation facility on approximately 1,300 acres located in Aylett, southwest of the intersection of Upshaw Road (Route 608) and King William Road (Route 30). It is anticipated that more or less 576 acres of the site will be developed with approximately 233,091 panels.

Contact Information: Mary E. Major, Department of Environmental Quality, 1111 East Main Street, Suite 1400, P.O. Box 1105, Richmond, VA 23218, telephone (804) 698-4423, FAX (804) 698-4319, or email mary.major@deq.virginia.gov.

DEPARTMENT OF MEDICAL ASSISTANCE SERVICES

Intent to Amend the Virginia State Plan for Medical Assistance Pursuant to § 1902(a)(13) of the Social Security Act (USC § 1396a(a)(13)) - Elimination of Medicaid Cost-Sharing

Public comment period: April 13, 2020, through May 12, 2020.

This notice is intended to satisfy the requirements of 42 CFR 447.57 and § 1902(a)(13) of the Social Security Act, 42 USC § 1396a(a)(13). A copy of this notice is available for public review from the contact listed at the end of the notice.

The Department of Medical Assistance Services is specifically soliciting input from stakeholders, providers, and beneficiaries on the potential impact of the proposed changes discussed in this notice. Submit comments or inquiries in writing within 30 days of this notice publication and review comments using the contact information at the end of this notice. Comments may also be submitted in writing on the Virginia Regulatory Town Hall public comment forum at https://townhall.virginia.gov/L/generalnotice.cfm.

The Virginia Department of Medical Assistance Services hereby affords the public notice of its intention to amend the Virginia State Plan for Medical Assistance to eliminate all Medicaid cost-sharing for all Medicaid services and all Medicaid members, effective March 13, 2020. The expiration date is August 31, 2020.

Contact Information: Emily McClellan, Regulatory Manager, Division of Policy and Research, Department of Medical Assistance Services, 600 East Broad Street, Suite 1300, Richmond, VA 23219, telephone (804) 371-4300, FAX (804) 786-1680, TDD (800) 343-0634, or email emily.mcclellan@dmas.virginia.gov.

STATE WATER CONTROL BOARD

Proposed Consent Special Order for Bear Island Paper WB LLC

An enforcement action is proposed for the Bear Island Paper WB LLC for alleged violations that occurred at Bear Island Paper WB LLC, Ashland, Virginia. The State Water Control Board proposes to issue a consent special order to Bear Island Paper WB LLC to address noncompliance with State Water Control Law. A description of the proposed action is available at the Department of Environmental Quality office listed or online at www.deq.virginia.gov. Jeff Reynolds will accept comments by email at jefferson.reynolds@deq.virginia.gov or by postal mail at Department of Environmental Quality, Piedmont Regional Office, 4949-A Cox Road, Glen Allen, VA 23060, from April 13, 2020, to May 13, 2020.

Proposed Enforcement Action for Celebrate Virginia South LLC

An enforcement action has been proposed for Celebrate Virginia South LLC for violations of the State Water Control Law and regulations at the Celebrate Virginia South development located in Fredericksburg City, Virginia. A description of the proposed action is available at the Department of Environmental Quality office listed or online at www.deq.virginia.gov. Jim Datko will accept comments by email at james.datko@deq.virginia.gov, or postal mail at Department of Environmental Quality, Northern Regional Office, 13901 Crown Court, Woodbridge, VA 22193, from April 14, 2020, through May 14, 2020.

Proposed Enforcement Action for Six-O-Five Mobile Home Group LLC

An enforcement action has been proposed for Six-O-Five Mobile Home Group LLC for violations of the State Water Control Law at the Six-O-Five Mobile Home Park sewage treatment plant facility located in Louisa County, Virginia. A description of the proposed action is available at the Department of Environmental Quality office listed or online at www.deq.virginia.gov. Jim Datko will accept comments by email at james.datko@deq.virginia.gov or postal mail at Department of Environmental Quality, Northern Regional Office, 13901 Crown Court, Woodbridge, VA 22193, from April 14, 2020, through May 14, 2020.

VIRGINIA WASTE MANAGEMENT BOARD

Proposed Consent Special Order for Bear Island Paper WB LLC

An enforcement action in the form of a consent special order has been proposed for Bear Island Paper WB LLC in Ashland, Virginia, for alleged violations of the Virginia Waste Management Act. A description of the proposed action is available at the Department of Environmental Quality office listed or online at www.deq.virginia.gov. Jeff Reynolds will accept comments by email at jefferson.reynolds@deq.virginia.gov, FAX at (804) 527-5106, or postal mail at Department of Environmental Quality, Piedmont Regional Office, 4949-A Cox Road, Glen Allen, VA 23060, from April 13, 2020, to May 13, 2020.

VIRGINIA CODE COMMISSION

Notice to State Agencies

Contact Information: Mailing Address: Virginia Code Commission, Pocahontas Building, 900 East Main Street, 8th Floor, Richmond, VA 23219; Telephone: (804) 698-1810; Email: varegs@dls.virginia.gov.

Meeting Notices: Section 2.2-3707 C of the Code of Virginia requires state agencies to post meeting notices on their websites and on the Commonwealth Calendar at https://commonwealthcalendar.virginia.gov.

Cumulative Table of Virginia Administrative Code Sections Adopted, Amended, or Repealed: A table listing regulation sections that have been amended, added, or repealed in the Virginia Register of Regulations since the regulations were originally published or last supplemented in the print version of the Virginia Administrative Code is available at http://register.dls.virginia.gov/documents
/cumultab.pdf
.

Filing Material for Publication in the Virginia Register of Regulations: Agencies use the Regulation Information System (RIS) to file regulations and related items for publication in the Virginia Register of Regulations. The Registrar's office works closely with the Department of Planning and Budget (DPB) to coordinate the system with the Virginia Regulatory Town Hall. RIS and Town Hall complement and enhance one another by sharing pertinent regulatory information.